Senior Engineering Project Manager - Manufacturing ExpansionLocation: Greater Columbus Area, OH
Contract: 12+ months with strong potential for extensions
Schedule: Full-time, onsite
Industry: Biotech / Pharmaceutical Manufacturing
This role will provide hands-on project management support for facilities, utilities, process equipment, automation, quality systems, and GMP manufacturing infrastructure associated with the expansion. The successful candidate will work closely with Engineering, Facilities, Manufacturing, Quality, Validation, Construction, and external contractors to drive project execution from planning through installation, commissioning, qualification, turnover, and operational readiness.
This is an excellent opportunity for a strong pharmaceutical or biotech project manager who understands the realities of capital project delivery in a regulated GMP environment: schedule pressure, cross-functional coordination, documentation discipline, quality expectations, and clean hand off to operations.
Key Responsibilities- Lead and manage assigned engineering, facilities,utilities, equipment, automation, and GMP infrastructure workstreams forthe New Albany manufacturing expansion.
- Support execution of a large-scale biotechmanufacturing capital project, including project planning, schedulemanagement, budget tracking, risk management, issue resolution, andmilestone reporting.
- Coordinate with stakeholders, engineering firms,construction contractors, equipment vendors, CQV teams, Quality Assurance,Manufacturing, Operations, and site leadership.
- Drive assigned scopes from design review andprocurement through installation, startup, commissioning, qualification,turnover, and operational readiness.
- Support readiness for GMP manufacturing operations,including punch list closure, turnover packages, qualificationsdocumentation, SOP readiness, and hand off to operations.
- Track project progress, identify schedule or budgetrisks, escalate issues appropriately, and drive practical resolution.
- Ensure project activities are executed in accordancewith applicable GMP requirements, engineering standards, site procedures,safety requirements, and quality expectations.
- Prepare and present project status updates for clientleadership and cross-functional project teams.
- Support change management, documentation control, fieldcoordination, and alignment between engineering execution andvalidation/quality requirements.
- Help ensure a disciplined transition from constructionand project execution into validated, compliant, operational manufacturingcapability.
RequirementsRequired Qualifications- Bachelor's degree in Engineering, ConstructionManagement, Life Sciences, or a related technical field; equivalentexperience will also be considered.
- Significant senior level experience managing engineering,facilities, utilities, capital, automation, or manufacturing projects in apharmaceutical, biotech, medical device, or regulated manufacturingenvironment.
- Strong understanding of GMP project execution,including commissioning, qualification, validation, quality documentation,turnover, and operational readiness.
- Demonstrated ability to manage multiple stakeholders,vendors, contractors, and internal project teams.
- Strong schedule, budget, resources, risk, and issuemanagement skills.
- Excellent written and verbal communication skills,including the ability to provide clear executive-level project updates.
- Ability to work effectively onsite in a fast-movingcapital project environment.
- Proficiency with project management tools such as MSProject, Primavera P6, Smartsheet, Excel, PowerPoint, or similarplatforms.
