Job Description

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:


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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.
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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.
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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.
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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:


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Education

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

Preferred

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