Process Specialist
AbbVie
Process Specialist
Job Description
AbbVie Ballytivnan is a Centre of Excellence for Precision High Volume Moulding and Auto-Assembly, and is a state-of-the-art Biologics aseptic fill finish facility.We are looking for a Single Use Process Specialist to join our Technical Operations Team in Ballytivnan, Sligo. You will work closely with site cross-functional teams and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes. This position reports to the NPI Technical Manager. This is an exciting time to join our Technical Operations team as we grow and bring new products and technologies to the site. To be successful in this role you need to be initiative-taking, have strong collaboration skills and be able to work to strict project timelines.Roles and ResponsibilitiesWork closely with site cross-functional team and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes.Lead and / or assist risk assessments for the introduction or modification of the product path including single use materials (e.g., pFMEA, SU RA, E&L assessment) including required change management activities.Interact with manufacturers and vendors on best practices and validation packages, and function as technical lead for SU complaints.Assist with the development of manufacturing process for new products including developing and/or reviewing process related documents e.g., Protocols/ Procedures/ Manufacturing Batch Records.Prepare and update specifications related to NPI materials and consumables, including single use materials used in the product path.Provide operational technical support for process related issue resolution, design experiments to investigate new processes or failure modes, assist and / or lead single use process related investigations.Monitor and analyse process data during the manufacturing.Support, supervise, and train operations personnel for SU processes.Adhere to and support all EHS&E standards, procedures, and policies. Other duties as assigned.
Locations
- Sligo, ie
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
50,000 - 80,000 USD / yearly
Source: AI estimated from job description
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Collaboration with cross-functional and global teamsintermediate
- Risk assessment (pFMEA, SU RA, E&L)intermediate
- Vendor interaction and technical leadershipintermediate
- Process development and documentationintermediate
- Technical support and investigationintermediate
- Data monitoring and analysisintermediate
- Training and supervisionintermediate
- EHS&E adherenceintermediate
Required Qualifications
- Initiative-taking (experience)
- Strong collaboration skills (experience)
- Ability to work to strict project timelines (experience)
Responsibilities
- Work closely with site cross-functional team and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes
- Lead and / or assist risk assessments for the introduction or modification of the product path including single use materials (e.g., pFMEA, SU RA, E&L assessment) including required change management activities
- Interact with manufacturers and vendors on best practices and validation packages, and function as technical lead for SU complaints
- Assist with the development of manufacturing process for new products including developing and/or reviewing process related documents e.g., Protocols/ Procedures/ Manufacturing Batch Records
- Prepare and update specifications related to NPI materials and consumables, including single use materials used in the product path
- Provide operational technical support for process related issue resolution, design experiments to investigate new processes or failure modes, assist and / or lead single use process related investigations
- Monitor and analyse process data during the manufacturing
- Support, supervise, and train operations personnel for SU processes
- Adhere to and support all EHS&E standards, procedures, and policies. Other duties as assigned
Tags & Categories
Process Specialist
AbbVie
Process Specialist
Job Description
AbbVie Ballytivnan is a Centre of Excellence for Precision High Volume Moulding and Auto-Assembly, and is a state-of-the-art Biologics aseptic fill finish facility.We are looking for a Single Use Process Specialist to join our Technical Operations Team in Ballytivnan, Sligo. You will work closely with site cross-functional teams and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes. This position reports to the NPI Technical Manager. This is an exciting time to join our Technical Operations team as we grow and bring new products and technologies to the site. To be successful in this role you need to be initiative-taking, have strong collaboration skills and be able to work to strict project timelines.Roles and ResponsibilitiesWork closely with site cross-functional team and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes.Lead and / or assist risk assessments for the introduction or modification of the product path including single use materials (e.g., pFMEA, SU RA, E&L assessment) including required change management activities.Interact with manufacturers and vendors on best practices and validation packages, and function as technical lead for SU complaints.Assist with the development of manufacturing process for new products including developing and/or reviewing process related documents e.g., Protocols/ Procedures/ Manufacturing Batch Records.Prepare and update specifications related to NPI materials and consumables, including single use materials used in the product path.Provide operational technical support for process related issue resolution, design experiments to investigate new processes or failure modes, assist and / or lead single use process related investigations.Monitor and analyse process data during the manufacturing.Support, supervise, and train operations personnel for SU processes.Adhere to and support all EHS&E standards, procedures, and policies. Other duties as assigned.
Locations
- Sligo, ie
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
50,000 - 80,000 USD / yearly
Source: AI estimated from job description
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Collaboration with cross-functional and global teamsintermediate
- Risk assessment (pFMEA, SU RA, E&L)intermediate
- Vendor interaction and technical leadershipintermediate
- Process development and documentationintermediate
- Technical support and investigationintermediate
- Data monitoring and analysisintermediate
- Training and supervisionintermediate
- EHS&E adherenceintermediate
Required Qualifications
- Initiative-taking (experience)
- Strong collaboration skills (experience)
- Ability to work to strict project timelines (experience)
Responsibilities
- Work closely with site cross-functional team and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes
- Lead and / or assist risk assessments for the introduction or modification of the product path including single use materials (e.g., pFMEA, SU RA, E&L assessment) including required change management activities
- Interact with manufacturers and vendors on best practices and validation packages, and function as technical lead for SU complaints
- Assist with the development of manufacturing process for new products including developing and/or reviewing process related documents e.g., Protocols/ Procedures/ Manufacturing Batch Records
- Prepare and update specifications related to NPI materials and consumables, including single use materials used in the product path
- Provide operational technical support for process related issue resolution, design experiments to investigate new processes or failure modes, assist and / or lead single use process related investigations
- Monitor and analyse process data during the manufacturing
- Support, supervise, and train operations personnel for SU processes
- Adhere to and support all EHS&E standards, procedures, and policies. Other duties as assigned
Tags & Categories