LL01-102225 C&Q Lead - Filling Operations

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:

• The C&Q Lead – Filling Operations: responsible for planning, executing, and managing all Commissioning and Qualification (C&Q) activities associated with aseptic Filling Lines and Support Systems in a GMP-regulated biotech facility. This role ensures that equipment, systems, and utilities are installed, commissioned, and qualified per design intent, user requirements, and regulatory expectations to support successful start-up and commercial readiness.

Key Responsibilities:

• Project Leadership & Planning
  • Lead and coordinate C&Q scope for Filling Operations, including:
  • Isolator-based filling lines (vials, syringes, cartridges)
  • Lyophilizers
  • Autoclaves, washers, depyrogenation tunnels
  • Associated utilities (WFI, clean steam, HVAC, compressed air)
• Develop and maintain the C&Q Master Plan and schedule for filling area systems.
• Interface closely with Process Engineering, Validation, QA, and Operations to align priorities and readiness milestones.
• Ensure adherence to GMP, GEP, and corporate engineering standards.

Commissioning & Qualification Execution

• Oversee development and approval of URS, FAT, SAT, IOQ protocols, and summary reports.
• Coordinate vendor FAT/SAT and punch-list resolution.
• Lead execution of C&Q testing for mechanical, automation, and process integration.
• Ensure robust data integrity and proper documentation within electronic validation systems (e.g., Kneat or ValGenesis).
• Manage Change Control and Deviation resolution related to equipment qualification.

Technical Oversight

• Serve as technical SME for aseptic filling equipment and integration with isolator technology and automation.
• Review and approve critical design and test documents (P&IDs, specifications, FDS/HDS/SDS, test scripts).
• Ensure utilities and equipment meet FDA, EMA, and Annex 1 standards for aseptic manufacturing.
• Ensure C&Q documentation meets regulatory expectations and site quality standards.
• Support Quality Assurance in audits and regulatory inspections related to facilities, utilities, and filling equipment.
• Prepare and present C&Q metrics and readiness reports to site and project leadership.

Cross-functional Collaboration

• Work closely with QA Validation, Automation, Process Engineering, and Operations to ensure smooth tech transfer and startup.
• Participate in project risk assessments, design reviews, and qualification readiness reviews.
• Mentor junior C&Q engineers and ensure consistent execution practices.

Qualifications:

Education

• Bachelor’s degree in Engineering (Mechanical, Chemical, or related discipline) or equivalent technical background.

Experience

• 8+ years of experience in Commissioning & Qualification within biotech or pharmaceutical manufacturing.
• Minimum 3 years leading C&Q for aseptic filling or sterile manufacturing operations.
• Strong knowledge of GMPs, GEPs, ASTM E2500, ISPE Baseline Guides, and Annex 1.

Technical Skills

• Experience with isolator-based filling systems, lyophilizers, and sterile utilities.
• Familiarity with automation integration (DeltaV, SCADA, BMS) and data integrity requirements.
• Hands-on experience with electronic validation platforms (e.g., Kneat, ValGenesis).
• Excellent communication and leadership skills.

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Preferred

• Experience in start-up or greenfield projects for biotech/sterile manufacturing sites.
• Demonstrated ability to lead multidisciplinary teams in GMP facilities.