Senior Process Engineer
Primary Talent Partners has a 12 month contract opening for a Senior Process Engineer to join a multinational pharmaceutical company for a fully remote position operating on EST hours with 25% travel to client sites.Pay: $73.00/hr - $83.00/hr Contract: 12 months,extensions likely, conversion possible Type: W-2, cannot support C2C or provide visa sponsorship Remote: Remote with 25% travel to external client sites.Summary: We are seeking a highly motivated individual for a technical operations engineer position.
This role will primarily support the commercial manufacture of Drug Product (Form / Fill) at the External Partner network sites inclusive of the responsibilities below.
Responsibilities include:
- Author, review, and maintain GMP technical documentation with clarity, accuracy, and compliance to applicable regulatory and quality requirements.
- Documents include: Change control ownership, protocols and technical reports, continued process verification (CPV) plans, data sets, trend analyses, and periodic reports
- Perform statistical data extraction and analysis to support proactive process analysis. Typical activities: Pull and validate production, quality, and process control data from relevant GMP sources or approved data trending systems, apply statistical process control (SPC), capability analysis, and other appropriate methods, create visualizations and summary metrics to support assessment outputs
- Contribute to continuous improvement initiatives, including data-driven process optimization and documentation standardization
- Floor support as needed for Person-In-Plant activities at External Partner
Education Minimum Requirement: Bachelor's degree in Chemical / Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Required Experience and Skills:
- Minimum of 6 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, or Engineering
- Min 3 years of experience supporting sterile / aseptic drug product filling (vials, syringes, etc.)
- Statistics experience
- Strong communication and teamwork skills
- Demonstrated ability to independently manage projects/work to schedule/deadlines
- Travel may be required but not to exceed 25%
Preferred Experience and Skills: Experience with isolator filling
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
Senior Process Engineer
Primary Talent Partners has a 12 month contract opening for a Senior Process Engineer to join a multinational pharmaceutical company for a fully remote position operating on EST hours with 25% travel to client sites.Pay: $73.00/hr - $83.00/hr Contract: 12 months,extensions likely, conversion possible Type: W-2, cannot support C2C or provide visa sponsorship Remote: Remote with 25% travel to external client sites.Summary: We are seeking a highly motivated individual for a technical operations engineer position.
This role will primarily support the commercial manufacture of Drug Product (Form / Fill) at the External Partner network sites inclusive of the responsibilities below.
Responsibilities include:
- Author, review, and maintain GMP technical documentation with clarity, accuracy, and compliance to applicable regulatory and quality requirements.
- Documents include: Change control ownership, protocols and technical reports, continued process verification (CPV) plans, data sets, trend analyses, and periodic reports
- Perform statistical data extraction and analysis to support proactive process analysis. Typical activities: Pull and validate production, quality, and process control data from relevant GMP sources or approved data trending systems, apply statistical process control (SPC), capability analysis, and other appropriate methods, create visualizations and summary metrics to support assessment outputs
- Contribute to continuous improvement initiatives, including data-driven process optimization and documentation standardization
- Floor support as needed for Person-In-Plant activities at External Partner
Education Minimum Requirement: Bachelor's degree in Chemical / Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Required Experience and Skills:
- Minimum of 6 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, or Engineering
- Min 3 years of experience supporting sterile / aseptic drug product filling (vials, syringes, etc.)
- Statistics experience
- Strong communication and teamwork skills
- Demonstrated ability to independently manage projects/work to schedule/deadlines
- Travel may be required but not to exceed 25%
Preferred Experience and Skills: Experience with isolator filling
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
