Position Summary
- Client is seeking a highly motivated individual for a technical operations contractor position.
- This role will primarily support the commercial manufacture of Drug Product (Form/Fill) at the client’s External Partner network sites inclusive of the responsibilities below.
Responsibilities:
- 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.
Travel Requirement: Remote role with 25% travel expected at the client’s External Partner network sites.
Qualifications:
Education (Min): 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.