Process Validation Engineer

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Process Validation Engineer (Contract)

Location: Pennsylvania

Duration: 8-12 months

Job Description:

We are seeking a highly skilled and motivated Process Validation Engineer to join our team on a contract basis and serve as a bridge between R&D and manufacturing. This is an excellent opportunity for anyone who is a Scientist in Vaccine Manufacturing Science and Commercialization – Bioreactor & Fermentation Development to become more involved on the design side. The successful candidate will represent validation as a Subject Matter Expert (SME) and provide validation oversight monitor project results and drive sustainability.

Key Responsibilities:

• Develop validation plans, protocols, and summary reports to perform shakedowns and functional testing. This role offers a unique chance for scientists to engage in the design and validation of critical equipment.
• Work closely with the Manufacturing Sciences and Technology (MSAT) team to develop technical documents for the drug product line. This collaboration provides an excellent opportunity for scientists to contribute to the design and optimization of drug product lines.
• Provide hands-on process and equipment support for the upstream area of an egg-based vaccine manufacturing facility, including execution of project start-ups for Harvesters, Centrifuge skid, Clarification, and Tangential Flow Filtration.
• Provide technical leadership and subject matter expertise for Equipment and Process Qualification (SAT, IQ, OQ, PQ) activities.
• Review and execute protocols, operate and troubleshoot automation equipment, and coordinate project management with vendors and contractors.
• Work independently and interface directly with personnel from multiple departments, including Technical Development, Manufacturing, Engineering, Manufacturing Support, MSAT, Quality Control (QC), and Quality Assurance (QA). This role allows scientists to engage with various teams and gain experience in the design and validation processes.
• Perform qualification of manufacturing equipment, facility, and utility systems (including CIP/SIP qualification), cleaning validation, and process validation. Responsibilities include drafting qualification protocols and summary reports, field execution, and data analysis.
  
  

Additional Responsibilities with MSAT Experience:

• Process Validation: Support industrialization, validation studies, and pre-approval inspections for drug products.
• Technical Support: Provide day-to-day assistance to manufacturing for process improvements, troubleshooting, and ensuring compliance with cGMP and regulatory standards.
• Technology Transfer: Enable the transfer of processes from development to manufacturing while driving innovation.
• Documentation: Write protocols, validation reports, and technical summaries to support process validation activities.
  
  

This role requires collaboration across teams, problem-solving skills, and a focus on continuous improvement to optimize performance and ensure product quality. It is an excellent opportunity for scientists in Vaccine Manufacturing Science and Commercialization – Bioreactor & Fermentation Development to expand their expertise and contribute to the design and validation of critical processes and equipment.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Proven experience in process validation within a pharmaceutical or biotechnology environment.
• Strong knowledge of GMP regulations and validation principles.
• Excellent problem-solving and analytical skills.
• Ability to work independently and as part of a team.
• Strong communication and interpersonal skills.
  
  

Additional Information:

This role is a contract position lasting 8-12 months, based in Pennsylvania. The successful candidate will have the opportunity to work with a leading pharmaceutical company and contribute to the development and validation of critical processes and equipment.

Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.