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Validation & Engineering Group, Inc. · 3 months ago

LL01-251006 Project Manager for Biotech Site

Holly Springs, NC

Full-time

Onsite

Senior Level

5+ years exp

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries including Biotechnology. The Project Manager will oversee the planning, design, installation, and start-up of biotechnology manufacturing facilities, ensuring compliance with regulatory standards and successful project delivery.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Lead all phases of biotech manufacturing projects: concept, basic/detailed design, procurement, construction, installation, commissioning, qualification, and turnover

Develop Project Execution Plans (PEP), project charters, detailed work-breakdown structures (WBS), integrated master schedules, and resource-loading plans

Ensure alignment with User Requirements Specifications (URS), Basis of Design (BOD), and manufacturing/operational needs

Coordinate construction of cleanrooms, classified areas (ISO 5-8), supporting clean utilities (WFI, clean steam, compressed air, gases), HVAC/BAS, and process automation

Develop and manage budget, forecasts, contingency, and cash flow

Manage bids, vendor selection, purchase orders, change orders, and invoice approvals

Prepare weekly and monthly progress reports for senior management and client stakeholders

Ensure all construction and start-up activities meet FDA/EMA cGMP, ISO, and corporate quality standards

Support risk-based CQV strategies aligned with ASTM E2500 and ISPE Baseline Guides

Oversee FAT/SAT, equipment installation verification, and coordination with CQV and QA/QC teams

Manage project risk register, mitigation plans, and change-control processes

Act as primary interface with the client, engineering firms, EPCM contractors, OEM vendors, site operations, and regulatory authorities

Facilitate design reviews, constructability assessments, HAZOP/FMEA workshops, and turnover planning sessions

Lead cross-functional meetings (engineering, construction, procurement, CQV, operations) and resolve technical or contractual issues

Promote a strong safety culture and adherence to EHS policies during all phases

Support start-up and operational readiness plans, including staff training, SOP coordination, and spare-parts strategies

Deliver turnover packages, as-built documentation, and regulatory-ready validation packages to manufacturing operations

Ensure project close-out with lessons learned and warranty tracking

Qualification

Biotech ManufacturingCGMP ComplianceCleanroom ConstructionProject ManagementPMP CertificationMS ProjectProcess Equipment InstallationStakeholder ManagementBilingual English/SpanishLeadership SkillsNegotiation Skills

Required

Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, Industrial, or related discipline)

5+ years of progressive project management experience in biotech/pharmaceutical manufacturing facilities, including capital project delivery

Demonstrated expertise with cleanroom construction, process equipment installation (bioreactors, isolators, filling lines), clean utilities (WFI, PW, CS, gases), and automation/BMS

Strong understanding of cGMP, FDA/EMA regulations, ISPE/GAMP 5, ASTM E2500

Proficiency in MS Project, Primavera P6, Smartsheet, or equivalent scheduling tools

Excellent leadership, negotiation, and stakeholder-management skills