Validation Specialist
5 days ago
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- CQV Specialist for Upstream Process Equipment
The CQV Specialist for Upstream Process Equipment will be responsible for the commissioning and qualification of systems supporting cell culture operations in a cGMP biotechnology manufacturing environment. The role includes the development and execution of protocols for bioreactors, media preparation systems, and other upstream support utilities. The successful candidate will collaborate with cross-functional teams and ensure compliance with FDA, EMA, and ICH regulatory requirements throughout the CQV lifecycle.
Key Responsibilities:
- Author, review, and execute commissioning and qualification protocols (IQ, OQ, PQ) for upstream equipment.
- Perform field inspections, verification activities, and system walkdowns.
- Support FAT/SAT execution with equipment vendors and engineering teams.
- Ensure systems are installed, configured, and performing according to URS, FS, and DS documentation.
- Troubleshoot equipment and resolve discrepancies or deviations during commissioning and qualification.
- Maintain traceability between user requirements, functional/design specifications, and testing protocols.
- Interface with automation, process engineering, QA, and manufacturing to drive schedule adherence and quality.
- Prepare and review summary reports, risk assessments, and impact assessments as part of the validation package.
Upstream Equipment in Scope:
- Single-use and stainless-steel bioreactors (SUB/SSB).
- Media preparation tanks and skids.
- Cell culture incubators.
- Control systems for temperature, pH, DO, agitation, and gas flow.
- Seed train and expansion vessels.
- Sterile filtration skids.
- Clean utilities interfacing with process systems (WFI, clean steam, process air).
Qualifications:
- Bachelor's degree in engineering, biotechnology, or related science field.
- 3–7 years of CQV experience in a biopharma GMP environment, with specific focus on upstream process systems.
- Proficiency in authoring and executing validation protocols, and working within electronic systems (e.g., Valgenesis, Kneat).
- Familiarity with industry regulations including FDA, EMA, ICH Q8–Q10, and ASTM E2500.
- Strong technical understanding of upstream biotechnology processes and associated automation platforms.
Preferred Skills:
- Experience with single-use technology (e.g., Sartorius, Thermo Fisher, Pall).
- Working knowledge of DeltaV or other process control systems.
- Exposure to tech transfer or facility startup projects in GMP settings.
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