A Pharmaceutical Manufacturing Process Engineer designs and maintains manufacturing equipment, facilities and processes for a pharmaceutical company. Maintains process controls for the specific sterile processing requirements of pharmaceutical manufacturing.
12 months Hours a week: 40 Hours 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:
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 and execution. 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.
Key Skills:
The ideal candidate should have around 6+ years of experience and strong technical operations experience in sterile liquids, injectables, vials, and syringes-not solid dosage. Key skills include change control ownership/execution, organization, planning, statistical understanding, cross-functional communication, teamwork, and ability to work independently. The role will involve process-related technical change controls across multiple sites, including work with SOPs, procedures, systems, emails, meetings, and stakeholder coordination. Travel will be up to 25%, mainly to North Carolina and Indiana.
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.). Prior experience and competency with change control. 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%(NC/Indiana).
