Lead Engineer, CSV
Bristol-Myers Squibb
Lead Engineer, CSV
Job Description
Supports equipment qualification and validation activities. Investigate and resolve Deviations, CAPA investigations and other potential issues. Configure and document the configuration of computerized systems to meet the requirements of 21CFR Part 11. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Completes all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards. Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems. Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls. Initiates, manages, and leads projects of moderate scope and complexity within their functional area. Manages projects of varying scope and complexity. Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment. Author quality procedures and training documents. Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners. Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment. Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. Support growing standardization efforts in the review and approval of Validation Deliverables. Promotes and provides excellent customer service and support. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests. Provides technical support and guidance on Validation, Quality Process, and equipment qualification issues. Interfaces with customers to ensure all expectations are being met. Ensure equipment, facilities and programs are maintained in compliance. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. BS degree or equivalent experience. Minimum 5 years of experience in FDA-regulated industry. Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry. Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance. Strong working knowledge of SDLC principles and standards. Ability to work with the end user to identify and document User and Functional Requirements. Knowledge of pharmaceutical laboratory and manufacturing systems. Experience executing equipment qualification documents. Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups. Strong working knowledge of MS Windows client and server technologies. Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously. Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors, and vendors. Experience with technical writing and document development / generation * Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification. Ability to sit, stand, walk and move within workspace for extended periods. Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling. Ability to work safely and effectively when working alone or working with others.
Key Responsibilities
- Support equipment qualification and validation activities
- Investigate and resolve Deviations, CAPA investigations and other potential issues
- Configure and document the configuration of computerized systems to meet the requirements of 21CFR Part 11
- Support the execution of equipment qualifications and validation protocols
- Supervise vendors for qualification functions
- Complete all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards
- Independently own all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
- Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls
- Initiate, manage, and lead projects of moderate scope and complexity within their functional area
- Manage projects of varying scope and complexity
- Maintain a positive relationship with all team members and site customers while promoting a positive learning, team environment
- Author quality procedures and training documents
- Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners
- Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment
- Support laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area
- Support growing standardization efforts in the review and approval of Validation Deliverables
- Promote and provide excellent customer service and support
- Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests
- Provide technical support and guidance on Validation, Quality Process, and equipment qualification issues
- Interface with customers to ensure all expectations are being met
- Ensure equipment, facilities and programs are maintained in compliance
Required Qualifications
- BS degree or equivalent experience
- Minimum 5 years of experience in FDA-regulated industry
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry
- Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
- Strong working knowledge of SDLC principles and standards
- Knowledge of pharmaceutical laboratory and manufacturing systems
- Experience executing equipment qualification documents
Skills Required
- Ability to work with the end user to identify and document User and Functional Requirements
- Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups
- Strong working knowledge of MS Windows client and server technologies
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion
- Ability to effectively manage multiple tasks and activities simultaneously
- Strong written and verbal communication skills along solid presentation skills
- Proficient at writing well-formulated emails and reports
- Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task
- Ability to effectively communicate with employees, contractors, and vendors
- Experience with technical writing and document development / generation
- Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- Ability to sit, stand, walk and move within workspace for extended periods
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling
- Ability to work safely and effectively when working alone or working with others
Locations
- Summit West NJ, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to work with the end user to identify and document User and Functional Requirementsintermediate
- Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groupsintermediate
- Strong working knowledge of MS Windows client and server technologiesintermediate
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completionintermediate
- Ability to effectively manage multiple tasks and activities simultaneouslyintermediate
- Strong written and verbal communication skills along solid presentation skillsintermediate
- Proficient at writing well-formulated emails and reportsintermediate
- Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned taskintermediate
- Ability to effectively communicate with employees, contractors, and vendorsintermediate
- Experience with technical writing and document development / generationintermediate
- Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualificationintermediate
Required Qualifications
- BS degree or equivalent experience (experience)
- Minimum 5 years of experience in FDA-regulated industry (experience)
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry (experience)
- Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance (experience)
- Strong working knowledge of SDLC principles and standards (experience)
- Knowledge of pharmaceutical laboratory and manufacturing systems (experience)
- Experience executing equipment qualification documents (experience)
Responsibilities
- Support equipment qualification and validation activities
- Investigate and resolve Deviations, CAPA investigations and other potential issues
- Configure and document the configuration of computerized systems to meet the requirements of 21CFR Part 11
- Support the execution of equipment qualifications and validation protocols
- Supervise vendors for qualification functions
- Complete all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards
- Independently own all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
- Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls
- Initiate, manage, and lead projects of moderate scope and complexity within their functional area
- Manage projects of varying scope and complexity
- Maintain a positive relationship with all team members and site customers while promoting a positive learning, team environment
- Author quality procedures and training documents
- Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners
- Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment
- Support laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area
- Support growing standardization efforts in the review and approval of Validation Deliverables
- Promote and provide excellent customer service and support
- Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests
- Provide technical support and guidance on Validation, Quality Process, and equipment qualification issues
- Interface with customers to ensure all expectations are being met
- Ensure equipment, facilities and programs are maintained in compliance
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Lead Engineer, CSV
Bristol-Myers Squibb
Lead Engineer, CSV
Job Description
Supports equipment qualification and validation activities. Investigate and resolve Deviations, CAPA investigations and other potential issues. Configure and document the configuration of computerized systems to meet the requirements of 21CFR Part 11. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Completes all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards. Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems. Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls. Initiates, manages, and leads projects of moderate scope and complexity within their functional area. Manages projects of varying scope and complexity. Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment. Author quality procedures and training documents. Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners. Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment. Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. Support growing standardization efforts in the review and approval of Validation Deliverables. Promotes and provides excellent customer service and support. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests. Provides technical support and guidance on Validation, Quality Process, and equipment qualification issues. Interfaces with customers to ensure all expectations are being met. Ensure equipment, facilities and programs are maintained in compliance. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. BS degree or equivalent experience. Minimum 5 years of experience in FDA-regulated industry. Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry. Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance. Strong working knowledge of SDLC principles and standards. Ability to work with the end user to identify and document User and Functional Requirements. Knowledge of pharmaceutical laboratory and manufacturing systems. Experience executing equipment qualification documents. Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups. Strong working knowledge of MS Windows client and server technologies. Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously. Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors, and vendors. Experience with technical writing and document development / generation * Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification. Ability to sit, stand, walk and move within workspace for extended periods. Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling. Ability to work safely and effectively when working alone or working with others.
Key Responsibilities
- Support equipment qualification and validation activities
- Investigate and resolve Deviations, CAPA investigations and other potential issues
- Configure and document the configuration of computerized systems to meet the requirements of 21CFR Part 11
- Support the execution of equipment qualifications and validation protocols
- Supervise vendors for qualification functions
- Complete all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards
- Independently own all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
- Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls
- Initiate, manage, and lead projects of moderate scope and complexity within their functional area
- Manage projects of varying scope and complexity
- Maintain a positive relationship with all team members and site customers while promoting a positive learning, team environment
- Author quality procedures and training documents
- Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners
- Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment
- Support laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area
- Support growing standardization efforts in the review and approval of Validation Deliverables
- Promote and provide excellent customer service and support
- Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests
- Provide technical support and guidance on Validation, Quality Process, and equipment qualification issues
- Interface with customers to ensure all expectations are being met
- Ensure equipment, facilities and programs are maintained in compliance
Required Qualifications
- BS degree or equivalent experience
- Minimum 5 years of experience in FDA-regulated industry
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry
- Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
- Strong working knowledge of SDLC principles and standards
- Knowledge of pharmaceutical laboratory and manufacturing systems
- Experience executing equipment qualification documents
Skills Required
- Ability to work with the end user to identify and document User and Functional Requirements
- Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups
- Strong working knowledge of MS Windows client and server technologies
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion
- Ability to effectively manage multiple tasks and activities simultaneously
- Strong written and verbal communication skills along solid presentation skills
- Proficient at writing well-formulated emails and reports
- Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task
- Ability to effectively communicate with employees, contractors, and vendors
- Experience with technical writing and document development / generation
- Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- Ability to sit, stand, walk and move within workspace for extended periods
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling
- Ability to work safely and effectively when working alone or working with others
Locations
- Summit West NJ, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to work with the end user to identify and document User and Functional Requirementsintermediate
- Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groupsintermediate
- Strong working knowledge of MS Windows client and server technologiesintermediate
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completionintermediate
- Ability to effectively manage multiple tasks and activities simultaneouslyintermediate
- Strong written and verbal communication skills along solid presentation skillsintermediate
- Proficient at writing well-formulated emails and reportsintermediate
- Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned taskintermediate
- Ability to effectively communicate with employees, contractors, and vendorsintermediate
- Experience with technical writing and document development / generationintermediate
- Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualificationintermediate
Required Qualifications
- BS degree or equivalent experience (experience)
- Minimum 5 years of experience in FDA-regulated industry (experience)
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry (experience)
- Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance (experience)
- Strong working knowledge of SDLC principles and standards (experience)
- Knowledge of pharmaceutical laboratory and manufacturing systems (experience)
- Experience executing equipment qualification documents (experience)
Responsibilities
- Support equipment qualification and validation activities
- Investigate and resolve Deviations, CAPA investigations and other potential issues
- Configure and document the configuration of computerized systems to meet the requirements of 21CFR Part 11
- Support the execution of equipment qualifications and validation protocols
- Supervise vendors for qualification functions
- Complete all qualification and validation documentation with accuracy, completeness, and compliance to BMS standards
- Independently own all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
- Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls
- Initiate, manage, and lead projects of moderate scope and complexity within their functional area
- Manage projects of varying scope and complexity
- Maintain a positive relationship with all team members and site customers while promoting a positive learning, team environment
- Author quality procedures and training documents
- Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners
- Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment
- Support laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area
- Support growing standardization efforts in the review and approval of Validation Deliverables
- Promote and provide excellent customer service and support
- Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests
- Provide technical support and guidance on Validation, Quality Process, and equipment qualification issues
- Interface with customers to ensure all expectations are being met
- Ensure equipment, facilities and programs are maintained in compliance
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories