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Engineering Project Manager – Manufacturing Expansion

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Job Description - Engineering Project Manager – Manufacturing Expansion


Engineering Project Manager – Manufacturing Expansion

Location: New Albany, OH
Contract:
12+ months
Schedule: Full-time, onsite
Industry: Biotech / Pharmaceutical Manufacturing

 

Automated Systems, Inc. is seeking an experienced Engineering Project Manager to support a major biotech manufacturing expansion in New Albany, Ohio. This is a 300,000 sq. ft expansion for product assembly, packaging, and distribution of medicines, including products used to treat cancer, cardiovascular disease, and autoimmune disease.

 

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 for the New Albany manufacturing expansion.

  • Support execution of a large-scale biotech manufacturing capital project, including project planning, schedule management, budget tracking, risk management, issue resolution, and milestone 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 and procurement through installation, startup, commissioning, qualification, turnover, and operational readiness.

  • Support readiness for GMP manufacturing operations, including punch list closure, turnover packages, qualifications documentation, SOP readiness, and hand off to operations.

  • Track project progress, identify schedule or budget risks, escalate issues appropriately, and drive practical resolution.

  • Ensure project activities are executed in accordance with applicable GMP requirements, engineering standards, site procedures, safety requirements, and quality expectations.

  • Prepare and present project status updates for client leadership and cross-functional project teams.

  • Support change management, documentation control, field coordination, and alignment between engineering execution and validation/quality requirements.

  • Help ensure a disciplined transition from construction and project execution into validated, compliant, operational manufacturing capability.






Requirements

Required Qualifications



  • Bachelor’s degree in Engineering, Construction Management, Life Sciences, or a related technical field; equivalent experience will also be considered.

  • Significant experience managing engineering, facilities, utilities, capital, automation, or manufacturing projects in a pharmaceutical, biotech, medical device, or regulated manufacturing environment.

  • 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 issue management 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-moving capital project environment.

  • Proficiency with project management tools such as MS Project, Primavera P6, Smartsheet, Excel, PowerPoint, or similar platforms.

 







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