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Supervisor, Downstream Lead - North Carolina

Non-Headquarters

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.

Supervisor, DSM - Downstream

Position Overview

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

What You'll Do

Project Phase

•    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, as applicable
•    Performs other operational readiness tasks as required, such as: document review/approval, team onboarding, and materials management
•    Supervises manufacturing associates on technical and operational topics, such as: area unit operations and equipment
•    Administers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employees

Operations Phase

•    Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates
•    Coordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages 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 direct reports have 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 but not limited to: maintenance, calibration activities and the use of manufacturing equipment
•    Administers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees
•    Performs other job as assigned

Who You Are

You have a high degree of knowledge and expertise of the operation of production equipment in their respective functional area. You have an understanding of manufacturing run cadence and order of shift activities. You have expertise in cGMP, safety and operational procedures. You have a strong cross functional partnership with Quality, Process Sciences, Process Engineering and others. You are able to create and maintain a collaborative and inclusive team. You have the ability to travel and have a valid passport.

Basic Requirements

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

Preferred Requirements

•    BA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects OR
•    Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects OR
•    Military Experience of equivalence
•    Experience in manufacturing of biological products, familiar with GMP/GLP requirements
•    Previous experience leading, supervising or managing others

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

When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com or @valspec.net.  Any other domains are impersonations and should be ignored.

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.

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