Associate, Equipment Commissioning & Qualification (ECQ) Delivery
Bristol-Myers Squibb
Associate, Equipment Commissioning & Qualification (ECQ) Delivery
Job Description
Maintain qualified equipment systems in compliance with policies, guidelines and procedures. Assist in the development of qualification protocols, and associated reports while adhering to a change management process. Participate in execution of equipment qualifications and validation protocols. Collaborate with vendors for qualification functions. Contribute to equipment qualification/validation activities. Aid in the creation of commissioning/qualification deliverables such as, Requirements Specifications, Design Specifications, Commissioning/Qualification protocols, Traceability Matrices, and Summary Reports. Support Change Management process. Basic understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. Basic understanding of pharmaceutical, manufacturing and laboratory systems. Strong written and verbal communication skills. Excellent interpersonal skills with experience dealing with a diverse workforce. Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to prioritize and effectively manage multiple tasks and activities simultaneously. Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business tools. 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. BS in Engineering or Science related discipline preferred, BS/BA required. Minimum of 2 years of experience performing/supporting activities in a GMP environment. Minimum of 2 years of experience in equipment, facility or utility qualification. Assist with equipment implementation projects including scheduling, site prep, installation, qualification, and turnover to business area. Support internal customer groups in the operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates. Provide troubleshooting assistance on equipment, facilities and utilities commissioning/qualification issues. Ensure equipment, facilities and programs are maintained in compliance. May participate in deviation investigations as SME. 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.
Key Responsibilities
- Maintain qualified equipment systems in compliance with policies, guidelines, and procedures
- Assist in the development of qualification protocols and associated reports
- Adhere to a change management process
- Participate in the execution of equipment qualifications and validation protocols
- Collaborate with vendors for qualification functions
- Contribute to equipment qualification/validation activities
- Aid in the creation of commissioning/qualification deliverables such as Requirements Specifications, Design Specifications, Commissioning/Qualification protocols, Traceability Matrices, and Summary Reports
- Support the Change Management process
- Assist with equipment implementation projects including scheduling, site prep, installation, qualification, and turnover to business area
- Support internal customer groups in the operation, calibration, and preventive maintenance of equipment
- Provide troubleshooting assistance on equipment, facilities, and utilities commissioning/qualification issues
- Ensure equipment, facilities, and programs are maintained in compliance
- May participate in deviation investigations as SME
Required Qualifications
- BS/BA degree required
- Minimum of 2 years of experience performing/supporting activities in a GMP environment
- Minimum of 2 years of experience in equipment, facility or utility qualification
Preferred Qualifications
- BS in Engineering or Science related discipline
Skills Required
- Basic understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices
- Basic understanding of pharmaceutical, manufacturing, and laboratory systems
- Strong written and verbal communication skills
- Excellent interpersonal skills with experience dealing with a diverse workforce
- Strong multi-tasking ability in conjunction with proven organizational skills
- Ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion
- Ability to prioritize and effectively manage multiple tasks and activities simultaneously
- Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook
- Innate ability to learn new software, such as corporate intranet and enterprise business tools
- 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 with others
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
Locations
- Summit West NJ, United States
Salary
Estimated Salary Rangemedium confidence
70,000 - 110,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Basic understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practicesintermediate
- Basic understanding of pharmaceutical, manufacturing, and laboratory systemsintermediate
- Strong written and verbal communication skillsintermediate
- Excellent interpersonal skills with experience dealing with a diverse workforceintermediate
- Strong multi-tasking ability in conjunction with proven organizational skillsintermediate
- Ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completionintermediate
- Ability to prioritize and effectively manage multiple tasks and activities simultaneouslyintermediate
- Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlookintermediate
- Innate ability to learn new software, such as corporate intranet and enterprise business toolsintermediate
- Ability to sit, stand, walk, and move within workspace for extended periodsintermediate
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pullingintermediate
- Ability to work safely and effectively when working alone or with othersintermediate
Required Qualifications
- BS/BA degree required (experience)
- Minimum of 2 years of experience performing/supporting activities in a GMP environment (experience)
- Minimum of 2 years of experience in equipment, facility or utility qualification (experience)
Preferred Qualifications
- BS in Engineering or Science related discipline (experience)
Responsibilities
- Maintain qualified equipment systems in compliance with policies, guidelines, and procedures
- Assist in the development of qualification protocols and associated reports
- Adhere to a change management process
- Participate in the execution of equipment qualifications and validation protocols
- Collaborate with vendors for qualification functions
- Contribute to equipment qualification/validation activities
- Aid in the creation of commissioning/qualification deliverables such as Requirements Specifications, Design Specifications, Commissioning/Qualification protocols, Traceability Matrices, and Summary Reports
- Support the Change Management process
- Assist with equipment implementation projects including scheduling, site prep, installation, qualification, and turnover to business area
- Support internal customer groups in the operation, calibration, and preventive maintenance of equipment
- Provide troubleshooting assistance on equipment, facilities, and utilities commissioning/qualification issues
- Ensure equipment, facilities, and programs are maintained in compliance
- May participate in deviation investigations as SME
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
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Associate, Equipment Commissioning & Qualification (ECQ) Delivery
Bristol-Myers Squibb
Associate, Equipment Commissioning & Qualification (ECQ) Delivery
Job Description
Maintain qualified equipment systems in compliance with policies, guidelines and procedures. Assist in the development of qualification protocols, and associated reports while adhering to a change management process. Participate in execution of equipment qualifications and validation protocols. Collaborate with vendors for qualification functions. Contribute to equipment qualification/validation activities. Aid in the creation of commissioning/qualification deliverables such as, Requirements Specifications, Design Specifications, Commissioning/Qualification protocols, Traceability Matrices, and Summary Reports. Support Change Management process. Basic understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. Basic understanding of pharmaceutical, manufacturing and laboratory systems. Strong written and verbal communication skills. Excellent interpersonal skills with experience dealing with a diverse workforce. Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to prioritize and effectively manage multiple tasks and activities simultaneously. Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business tools. 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. BS in Engineering or Science related discipline preferred, BS/BA required. Minimum of 2 years of experience performing/supporting activities in a GMP environment. Minimum of 2 years of experience in equipment, facility or utility qualification. Assist with equipment implementation projects including scheduling, site prep, installation, qualification, and turnover to business area. Support internal customer groups in the operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates. Provide troubleshooting assistance on equipment, facilities and utilities commissioning/qualification issues. Ensure equipment, facilities and programs are maintained in compliance. May participate in deviation investigations as SME. 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.
Key Responsibilities
- Maintain qualified equipment systems in compliance with policies, guidelines, and procedures
- Assist in the development of qualification protocols and associated reports
- Adhere to a change management process
- Participate in the execution of equipment qualifications and validation protocols
- Collaborate with vendors for qualification functions
- Contribute to equipment qualification/validation activities
- Aid in the creation of commissioning/qualification deliverables such as Requirements Specifications, Design Specifications, Commissioning/Qualification protocols, Traceability Matrices, and Summary Reports
- Support the Change Management process
- Assist with equipment implementation projects including scheduling, site prep, installation, qualification, and turnover to business area
- Support internal customer groups in the operation, calibration, and preventive maintenance of equipment
- Provide troubleshooting assistance on equipment, facilities, and utilities commissioning/qualification issues
- Ensure equipment, facilities, and programs are maintained in compliance
- May participate in deviation investigations as SME
Required Qualifications
- BS/BA degree required
- Minimum of 2 years of experience performing/supporting activities in a GMP environment
- Minimum of 2 years of experience in equipment, facility or utility qualification
Preferred Qualifications
- BS in Engineering or Science related discipline
Skills Required
- Basic understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices
- Basic understanding of pharmaceutical, manufacturing, and laboratory systems
- Strong written and verbal communication skills
- Excellent interpersonal skills with experience dealing with a diverse workforce
- Strong multi-tasking ability in conjunction with proven organizational skills
- Ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion
- Ability to prioritize and effectively manage multiple tasks and activities simultaneously
- Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook
- Innate ability to learn new software, such as corporate intranet and enterprise business tools
- 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 with others
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
Locations
- Summit West NJ, United States
Salary
Estimated Salary Rangemedium confidence
70,000 - 110,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Basic understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practicesintermediate
- Basic understanding of pharmaceutical, manufacturing, and laboratory systemsintermediate
- Strong written and verbal communication skillsintermediate
- Excellent interpersonal skills with experience dealing with a diverse workforceintermediate
- Strong multi-tasking ability in conjunction with proven organizational skillsintermediate
- Ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completionintermediate
- Ability to prioritize and effectively manage multiple tasks and activities simultaneouslyintermediate
- Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlookintermediate
- Innate ability to learn new software, such as corporate intranet and enterprise business toolsintermediate
- Ability to sit, stand, walk, and move within workspace for extended periodsintermediate
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pullingintermediate
- Ability to work safely and effectively when working alone or with othersintermediate
Required Qualifications
- BS/BA degree required (experience)
- Minimum of 2 years of experience performing/supporting activities in a GMP environment (experience)
- Minimum of 2 years of experience in equipment, facility or utility qualification (experience)
Preferred Qualifications
- BS in Engineering or Science related discipline (experience)
Responsibilities
- Maintain qualified equipment systems in compliance with policies, guidelines, and procedures
- Assist in the development of qualification protocols and associated reports
- Adhere to a change management process
- Participate in the execution of equipment qualifications and validation protocols
- Collaborate with vendors for qualification functions
- Contribute to equipment qualification/validation activities
- Aid in the creation of commissioning/qualification deliverables such as Requirements Specifications, Design Specifications, Commissioning/Qualification protocols, Traceability Matrices, and Summary Reports
- Support the Change Management process
- Assist with equipment implementation projects including scheduling, site prep, installation, qualification, and turnover to business area
- Support internal customer groups in the operation, calibration, and preventive maintenance of equipment
- Provide troubleshooting assistance on equipment, facilities, and utilities commissioning/qualification issues
- Ensure equipment, facilities, and programs are maintained in compliance
- May participate in deviation investigations as SME
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
Answer 10 quick questions to check your fit for Associate, Equipment Commissioning & Qualification (ECQ) Delivery @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs