Supervisor, Downstream Lead - North Carolina

Supervisor, Downstream Lead - North Carolina 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 Overview This role leads a shift team and is responsible for manufacturing bulk drug substance. The facility operates 24 / 7; the role may require flexibility with working hours.

What You’ll Do

Supports Factory Acceptance Testing (FAT) at the vendor site as required.

Supports Site Acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation.

Performs other operational readiness tasks such as document review / approval, team onboarding, and materials management.

Supervises manufacturing associates on technical and operational topics, including area unit operations and equipment.

Administers company policies such as travel & expense, time reporting, and time off that directly impact employees.

Provides on-the-floor leadership for a shift team of up to 7‑10 manufacturing associates.

Coordinates execution of the manufacturing schedule through daily shift assignments and lead daily huddles, managing escalations.

Fosters an inclusive, people‑first culture with regular communication, conducting 1 : 1s on a defined cadence with direct reports.

Maintains a safe and cGMP‑compliant environment by ensuring correct and up‑to‑date training.

Supports manufacturing investigations and continuous improvement projects.

Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment such as maintenance and calibration.

Administers company policies such as time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees.

Performs other job duties as assigned.

Who You Are You have a high degree of knowledge and expertise in the operation of production equipment in your functional area. You understand manufacturing run cadence and order of shift activities, possess cGMP, safety, and operational procedure knowledge, and have strong cross‑functional partnerships with Quality, Process Sciences, Process Engineering, and others. You are capable of creating and maintaining a collaborative, inclusive team and are able to travel and hold a valid passport.

Basic Requirements

High School Diploma or GED with 8 years of experience in a similar role in large pharma / biotech operations or projects.

Preferred Requirements

BA / BS in Life Sciences with 4+ years of experience in a similar role in large pharma / biotech operations or projects.

Associate’s Degree in Life Sciences with 6+ years of experience in a similar role in large pharma / biotech operations or projects.

Military experience of equivalence.

Experience in manufacturing of biological products and familiarity with GMP / GLP requirements.

Previous experience leading, supervising, or managing others.

Valspec offers a standout culture, a fantastic work environment, and very competitive benefits, including premium medical, 401(k) match, tuition reimbursement, and other unique incentives.

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 a professional environment free of discrimination or harassment and are proud to be a Drug‑Free Workplace.

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