Process Validation Engineer

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.

Position Summary

Our client is seeking an experienced Process Engineer to support process validation and Process Performance Qualification (PPQ) readiness activities at a biopharmaceutical manufacturing facility in Sanford, NC. This role will focus on validation strategy development, protocol authorship, qualification planning, and cross-functional execution support to ensure successful PPQ implementation and GMP compliance.

The successful candidate will work closely with Manufacturing, Quality, Engineering, and Validation teams to drive process qualification activities, manage validation studies, and support issue resolution throughout project execution.

Responsibilities

• Assess current process validation activities and identify gaps requiring remediation.
• Develop process validation strategies, action plans, and implementation roadmaps.
• Author validation protocols, reports, and supporting GMP documentation.
• Develop qualification strategies for:
  • Solution mixing operations
  • Process hold studies
  • In-process hold qualifications
  • Container hold studies
• Develop airflow visualization (AFV) study strategies for Grade A Biological Safety Cabinets.
• Coordinate and track execution of process qualification and validation activities.
• Manage scheduling, documentation, and execution support for hold studies and related validation efforts.
• Review Process FMEA outputs and support alignment of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
• Partner with Manufacturing, Quality, Engineering, and Subject Matter Experts to ensure successful execution of qualification activities.
• Participate in project meetings and support validation planning, issue management, and readiness efforts.

Required Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Experience supporting process validation and PPQ readiness within a biopharmaceutical or pharmaceutical manufacturing environment.
• Strong technical writing experience, including protocol and report authorship.
• Experience coordinating qualification studies and validation execution activities.
• Working knowledge of:
  • GMP regulations and compliance requirements
  • Process validation principles
  • Risk assessment methodologies, including FMEA
• Strong organizational, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Experience supporting biologics manufacturing operations.
• Experience with process hold studies, container hold studies, and mixing qualifications.
• Familiarity with airflow visualization (AFV) studies within aseptic manufacturing environments.
• Experience working in FDA-regulated manufacturing facilities.

Additional Information

• Primarily onsite in Sanford, NC.
• Limited remote work may be considered with prior approval.
• Full-time contract position (40 hours per week).
• Estimated duration: approximately nine (9) months.

At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:

• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• And more — all designed to support your growth, well-being, and future.

Join a team where your contributions matter, your development is prioritized, and your success is shared.