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:
- Commissioning and Qualification Specialist – Laboratory Systems (QC)
Position Summary:
The Commissioning and Qualification (C&Q) Specialist for Laboratory Systems in QC is responsible for ensuring the successful implementation, validation, and qualification of laboratory systems used in Quality Control environments. This role involves planning, executing, and documenting commissioning and qualification activities in compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and regulatory standards. The C&Q Specialist will collaborate with cross-functional teams, including QC, IT, engineering, and validation, to support the lifecycle management of laboratory systems.
Key Responsibilities:
1. Commissioning Activities
- Perform installation and operational checks for laboratory equipment and systems.
- Develop commissioning protocols and execute commissioning activities for new or upgraded laboratory systems.
- Identify and resolve technical issues during commissioning.
2. Qualification & Validation
- Author and execute qualification protocols (IQ, OQ, PQ) for laboratory systems, including HPLC, GC, spectrophotometers, and other analytical equipment.
- Ensure qualification and validation activities meet regulatory requirements and company standards.
- Manage deviations, CAPAs, and change controls related to laboratory systems.
3. Documentation
- Create and maintain accurate and complete documentation, including protocols, test scripts, reports, and SOPs.
- Ensure traceability of all qualification and validation activities.
4. Compliance and Risk Management
- Ensure compliance with global regulatory standards (e.g., FDA, EMA, ICH) and industry guidelines.
- Conduct risk assessments for laboratory systems and processes to determine the level of qualification required.
5. Lifecycle Management
- Support the periodic review and requalification of laboratory systems.
- Coordinate system upgrades, decommissioning, and troubleshooting.
6. Cross-Functional Collaboration
- Partner with QC, validation, IT, and engineering teams to ensure seamless implementation and qualification of laboratory systems.
- Provide support during regulatory audits and inspections.
7. Training
- Train QC personnel on the proper use and maintenance of qualified laboratory systems.
Qualifications
1. Education
- Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific discipline. Advanced degree preferred.
2. Experience
- 3–5 years of experience in commissioning, qualification, and validation of laboratory systems in a GMP/GLP-regulated environment.
- Hands-on experience with QC laboratory equipment and computerized systems (e.g., CDS, LIMS).
- Familiarity with data integrity requirements and 21 CFR Part 11 compliance.
3. Skills
- Strong technical writing skills for developing protocols and reports.
- Proficient in risk assessment and troubleshooting.
- Excellent project management and organizational abilities.
- Strong interpersonal and communication skills for cross-functional collaboration.
4. Knowledge
- In-depth knowledge of regulatory standards and guidelines, including USP, ICH Q7/Q9/Q10, and ISO standards.
- Familiarity with GAMP5 principles for computerized systems validation.
Preferred Qualifications
- Certification in C&Q or validation (e.g., ISPE).
- Experience with QC data systems like Empower, LabWare LIMS, or equivalent.
- Knowledge of Lean Six Sigma principles.
Working Conditions
- Office and laboratory environment.
- Occasional travel to other company sites or vendor facilities.
- Flexibility for extended hours during critical project phases.
