Validation & Engineering Group Inc.
Project Manager for Biotech Site
Validation & Engineering Group Inc., Holly Springs, North Carolina, United States, 27540
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 - Biotech Manufacturing Projects
Position Summary: The Project Manager will oversee the planning, design, installation and start-up of
biotechnology manufacturing facilities
and/or process systems. This role ensures successful delivery of
cGMP-compliant production suites, clean utilities, process equipment, and supporting infrastructure , coordinating multidisciplinary teams from concept through operational readiness. The PM will manage cost, schedule, risk, and quality while maintaining strict compliance with regulatory standards and site safety policies. Key Responsibilities
1. Project Planning & Execution
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. 2. Budget, Schedule & Cost Control
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. 3. Quality, Compliance & Risk
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. 4. Stakeholder & Team Leadership
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. 5. Operational Readiness & Turnover
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. Required Qualifications
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. Preferred / Desirable
PMP® or equivalent project management certification. Experience in
single-use systems, cell & gene therapy, aseptic processing, and high-potency API containment. Familiarity with
LEED commissioning (Fundamental, Enhanced, Envelope)
and sustainable facility practices. Working knowledge of
Procore, Kneat, Bluebeam, Autodesk ACC/BIM, SAP/Oracle ERP. Bilingual English/Spanish
highly desirable for Puerto Rico and LATAM projects. Core Competencies
Strategic leadership of multi-million-dollar CAPEX programs. Risk-based decision-making in highly regulated environments. Strong interpersonal and communication skills to align diverse teams. Commitment to
EHS, quality, and schedule-driven execution.
(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 - Biotech Manufacturing Projects
Position Summary: The Project Manager will oversee the planning, design, installation and start-up of
biotechnology manufacturing facilities
and/or process systems. This role ensures successful delivery of
cGMP-compliant production suites, clean utilities, process equipment, and supporting infrastructure , coordinating multidisciplinary teams from concept through operational readiness. The PM will manage cost, schedule, risk, and quality while maintaining strict compliance with regulatory standards and site safety policies. Key Responsibilities
1. Project Planning & Execution
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. 2. Budget, Schedule & Cost Control
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. 3. Quality, Compliance & Risk
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. 4. Stakeholder & Team Leadership
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. 5. Operational Readiness & Turnover
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. Required Qualifications
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. Preferred / Desirable
PMP® or equivalent project management certification. Experience in
single-use systems, cell & gene therapy, aseptic processing, and high-potency API containment. Familiarity with
LEED commissioning (Fundamental, Enhanced, Envelope)
and sustainable facility practices. Working knowledge of
Procore, Kneat, Bluebeam, Autodesk ACC/BIM, SAP/Oracle ERP. Bilingual English/Spanish
highly desirable for Puerto Rico and LATAM projects. Core Competencies
Strategic leadership of multi-million-dollar CAPEX programs. Risk-based decision-making in highly regulated environments. Strong interpersonal and communication skills to align diverse teams. Commitment to
EHS, quality, and schedule-driven execution.