We are looking to hire a validation specialist for a well-established pharmaceutical manufacturer in Swiftwater, PA!

Job Duties:

• Write protocols, reports, procedures and memos as needed to support viral vaccine drug substance manufacturing activities (upstream processes, downstream purification, products and associated test methods) as they relate to engineering, investigational, definition, development and process validation runs
• Support execution and documentation of engineering, development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition, development and process validation runs.
• Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
• Partner with Engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment
• Provide technical assistance to manufacturing and quality operations for process troubleshooting improvement, technical transfer and health authority inspections.

Qualifications:

• BS or MS in basic sciences, math, engineering or pharmacy with 2+ years’ experience or PhD with experience in biological processes or analytics in a cGMP environment.
• Expertise in one or more upstream/downstream process unit operation design typically used in biotech / vaccine manufacturing (seed expansion, viral growth and cell culture egg processes, harvest / clarification, purification, sterile filtration) as well as project / engineering lifecycle.
• Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
• Experience in equipment start-up, qualification and validation is preferred.
• Prior experience preparing and executing process performance qualification documents (PPQ) preferred.

Covid-19 vaccine is required
Please reply with your resume for review. We look forward to speaking with you!

ComServe is an Equal Opportunity employer – Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability or protected veteran status.

Job Type: Full-time

Pay: $50.00 - $59.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Work Location: In person

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