Valspec
Life Sciences
CQVConsultant
Neural analysis suggests this role is
optimal for Senior candidates.
“CQV Consultant at Valspec. Skills: CQV lifecycle activities, commissioning, qualification, validation. Execute CQV lifecycle activities including commissioning, IQ/OQ, and field verification. Support startup and qualification of GMP manufacturing equipment and utility systems”
What You'll Achieve.
meet their capital project and lifecycle maintenance goals; ensure that life-changing drugs are available to those who need others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies
Industry & Context.
Candidates must be legally eligible to work in the United States without company sponsorship., not interested in working on a corp-to-corp basis with other companies
What They're Looking For.
Must Have
Prior CQV experience in pharmaceutical, biotech, or GMP-regulated manufacturing environments, knowledge of commissioning and qualification processes, Experience supporting one or more of the following: Upstream, Downstream, CIP, PSE, or Clean Utilities systems, Familiarity with GMP documentation practices and regulatory requirements, Ability to work onsite in Holly Springs, NC on a full-time basis, communication and cross-functional collaboration skills
Nice to Have
Large-scale biologics or vaccine manufacturing projects, Startup or greenfield facility experience, Experience with DeltaV, MES, or automated process systems, Knowledge of clean utilities including WFI, clean steam, compressed gases, and purified water systems
What You'll Do.
Execute CQV lifecycle activities including commissioning
and field verification
Support startup and qualification of GMP manufacturing equipment and utility systems
and execute validation documentation and protocols
Support deviation investigations
Ensure compliance with GMP
and regulatory requirements
Participate in walkdowns
and punch-list resolution
Maintain accurate documentation in accordance with data integrity and quality standards
How You'll Work.
Team & Collaboration
Coordinate with engineering, operations, quality, automation, and project teams; cross-functional collaboration
Communication Scope
communication
Process & Methodology
capital project
Full Job Description
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. CQV Consultant – Upstream / Downstream / CIP / PSE / Clean Utilities Location: Holly Springs (100% Onsite) Type: Long-Term Contract Start Date: ASAP Overview We are seeking experienced CQV Consultants to support a major biopharmaceutical manufacturing project in Holly Springs, NC. This is a long-term onsite opportunity supporting commissioning, qualification, and validation activities across multiple process and utility systems in a GMP manufacturing environment. We are specifically looking for strong “A+” level consultants with hands-on pharmaceutical or biotech project experience supporting large-scale manufacturing operations. We are hiring CQV professionals with experience in one or more of the following areas: Upstream Processing Downstream Processing CIP (Clean-in-Place) Systems PSE (Process Support Equipment) Clean Utilities Key Responsibilities Execute CQV lifecycle activities including commissioning, IQ/OQ, and field verification Support startup and qualification of GMP manufacturing equipment and utility systems Author, review, and execute validation documentation and protocols Coordinate with engineering, operations, quality, automation, and project teams Support deviation investigations, change controls, and CAPA activities Ensure compliance with GMP, FDA, and regulatory requirements Participate in walkdowns, system turnover, a
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