Job Description
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:
- Project Manager (Aseptic Equipment & Processes)
The Project Manager (PM) will lead and coordinate projects involving aseptic equipment, sterile manufacturing processes, and cleanroom environments within regulated biotech or pharmaceutical facilities. This role ensures projects are delivered on time, within budget, and in compliance with GMP, FDA, and global regulatory standards, while maintaining strict aseptic control and contamination-prevention practices.
Key ResponsibilitiesProject Management
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Lead end-to-end project execution for aseptic manufacturing equipment and systems, including scope definition, scheduling, budgeting, and risk management
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Develop and maintain detailed project plans, timelines, and resource forecasts
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Coordinate cross-functional teams including Engineering, Manufacturing, QA, Validation, Automation, and external vendors
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Manage change control, deviations, and CAPAs related to project execution
Aseptic Equipment & Process Oversight
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Manage projects involving aseptic filling lines, isolators, RABS, autoclaves, depyrogenation tunnels, lyophilizers, CIP/SIP systems, sterile transfer systems, and clean utilities
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Ensure aseptic techniques are incorporated into equipment design, installation, and operation
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Review URS, FDS, DDS, P&IDs, layouts, and vendor submittals for aseptic compliance
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Support FAT, SAT, commissioning, and qualification (IQ/OQ/PQ) activities
GMP & Regulatory Compliance
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Ensure compliance with FDA cGMPs, EU GMP Annex 1, ISO cleanroom standards, and internal quality systems
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Partner with QA and Validation to ensure proper documentation and audit readiness
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Support regulatory inspections and client audits as required
Stakeholder & Vendor Management
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Serve as the primary point of contact for internal stakeholders, clients, and equipment vendors
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Manage vendor performance, schedules, and deliverables
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Lead technical and project status meetings and provide clear executive reporting
Required Qualifications
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Bachelor’s degree in Engineering, Life Sciences, or related technical field
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8+ years of project management experience in biotech/pharmaceutical manufacturing
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Demonstrated experience with aseptic processing equipment and sterile manufacturing environments
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Strong understanding of GMP, contamination control, and cleanroom operations
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Experience managing equipment lifecycle from design through qualification
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Excellent communication, leadership, and organizational skills
Preferred Qualifications
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PMP or equivalent project management certification
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Experience with Annex 1 implementation or contamination control strategies (CCS)
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Familiarity with commissioning & qualification (C&Q), validation protocols, and CQV documentation
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Experience working with CMOs, CDMOs, or large-scale commercial aseptic facilities
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Knowledge of automation platforms (e.g., DeltaV, Siemens, Rockwell) is a plus
Key Competencies
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Aseptic risk awareness and decision-making
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Cross-functional leadership in regulated environments
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Strong attention to detail and documentation quality
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Ability to manage multiple complex projects simultaneously
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Proactive problem-solving and stakeholder alignment