Project Manager – Capital Projects & Packaging Operations

BioTalent; Ohio; On-site; USD 130,000 - 190,000; Full time

Job summary

BioTalent is partnering with a leading global pharmaceutical manufacturer to recruit an experienced Senior Project Manager to lead high-value capital projects within a GMP manufacturing environment. This role oversees packaging and manufacturing investments from concept through handover, coordinating engineering, construction, CQV, and operations teams.

The ideal candidate has 10+ years in capital project delivery within regulated pharma settings, with strong leadership, budgeting, and

Qualifications

• Bachelor’s degree in engineering or a related technical discipline required.
• 10+ years of project management experience delivering capital projects in regulated manufacturing.
• Experience managing projects through design, construction, commissioning, qualification and start-up.
• Experience with packaging line installations and expansions.

Responsibilities

• Lead capital projects from concept through design, construction, commissioning, qualification and handover.
• Establish governance, execution strategies, charters, and stakeholder engagement plans.
• Manage scope, budget, schedule, risks and change control against baselines.
• Provide updates to senior leadership including forecasts and variances.
• Drive design development, reviews, constructability assessments and technical decisions.
• Coordinate engineering consultants, contractors, equipment vendors, CQV teams, and operations.
• Define packaging requirements including throughput, OEE targets, labelling and serialization, and related equipment qualification.

Skills

Project management

Leadership

Stakeholder management

Cross-functional teams

Communication

CQV knowledge

Validation basics

Education

Bachelor's Degree in Engineering or related technical discipline

Job description

BioTalent is partnering with a leading global pharmaceutical manufacturer to recruit an experienced Senior Project Manager to lead high-value capital projects within a GMP manufacturing environment.

This position will play a critical role in delivering large-scale packaging and manufacturing investments, overseeing projects from concept and design through construction, commissioning, qualification, and operational handover. The successful candidate will have a proven track record managing complex pharmaceutical capital projects and working across engineering, construction, CQV, and operations teams.

Key Responsibilities

• Lead capital projects from initial concept through design, construction, commissioning, qualification, and operational handover.
• Establish project governance, execution strategies, project charters, and stakeholder engagement plans.
• Manage project scope, budget, schedule, risks, and change control processes against approved baselines.
• Provide regular updates to senior leadership and steering committees, including project forecasts and variance analysis.
• Drive design development activities, design reviews, constructability assessments, and technical decision-making.
• Coordinate multidisciplinary teams including engineering consultants, construction contractors, equipment vendors, CQV teams, and operations stakeholders.
• Define packaging requirements including:
• Throughput and OEE targets
• Vision inspection systems
• Labelling and serialization requirements
• Manage packaging equipment suppliers through specification development, FAT, installation, commissioning, and SAT activities.
• Develop installation and shutdown strategies to minimize impact on ongoing manufacturing operations.
• Ensure compliance with GMP standards and support operational readiness planning and successful project handover.

Required Experience

• Bachelor's Degree in Engineering or a related technical discipline.
• 10+ years of project management experience delivering capital projects within pharmaceutical, biotech, or highly regulated manufacturing environments.
• Demonstrated experience managing projects through design, construction, commissioning, qualification, and start-up.
• Packaging line installations
• Packaging line expansions or modifications
• Proven ability to manage project budgets, schedules, stakeholders, and cross-functional teams.
• Experience leading capital projects with a Total Installed Cost (TIC) exceeding $30M.
• Exceptional communication, leadership, and stakeholder management skills.

Preferred Experience

• PMP certification.
• Knowledge of GMP regulations and validation requirements.
• Experience working within active pharmaceutical manufacturing facilities.
• Exposure to CQV, equipment qualification, and operational readiness programs.