Owns end-to-end delivery of assigned facility, utility, and equipment projects from concept through turnover to Operations, acting as the primary point of contact for scope, schedule, budget, and quality.
Develops and maintains integrated program plans, including scope definition, milestones, resource plans, budgets, and risk registers for facility buildouts, renovations, and equipment installations.
Coordinates internal resources and external partners (contractors, vendors, commissioning and qualification providers) to execute the program scope in a highly regulated environment.
Leads regular project meetings, prepares status reports, and communicates progress, risks, and mitigation strategies to stakeholders and site leadership.
Identifies critical path activities, dependencies, and potential bottlenecks; develops and implements recovery plans as needed to maintain project commitments.
Plans, organizes, and directs a wide variety of capital projects including new construction, facility expansions, laboratory and cleanroom buildouts, and infrastructure upgrades.
Partners with Facilities, Manufacturing, Quality, EHS, and external design teams to ensure facility layouts and building systems (HVAC, utilities, process piping, electrical, controls) meet operational, regulatory, and safety requirements.
Partners with multiple project teams to ensure completion of all ongoing projects.
Ensures design and construction are aligned with cGMP requirements for biopharmaceutical operations, including controlled environments, material and personnel flows, and segregation strategies.
Monitors construction progress, reviews field changes, and assists in resolution of site issues; evaluates and recommends approval of change orders that impact scope, cost, or schedule.
Leads or coordinates commissioning and qualification activities for new and modified equipment, utilities, and systems in partnership with Engineering, Validation, and Quality.
Supports development and execution of CQV deliverables (URS, design reviews, FAT/SAT, IQ/OQ/PQ protocols, summary reports) to ensure equipment is fit for intended use and compliant with regulatory expectations.
Ensures program and project timelines account for CQV activities, documentation reviews, and regulatory/QA approvals required for GMP release.
Drives resolution of technical and validation issues during startup and qualification, coordinating cross-functional troubleshooting and escalation as needed.
Ensures projects are executed in compliance with applicable building and safety codes, environmental regulations, and company standards.
Partners with EHS to plan and monitor construction safety programs and ensure contractor compliance with site safety requirements.
Supports internal and external audits/inspections related to facilities, equipment, and validation, including preparation and presentation of project and CQV documentation.
Develops program and project budgets and cash flow forecasts; tracks and reports capital spend against approved funding.
Reviews and evaluates vendor and contractor proposals, scopes of work, and change orders; provides recommendations for selection and award.
Reviews invoices in line with completion milestones and contract terms.
Facilitates cross-functional communication and decision-making to ensure alignment between Engineering, Operations, Quality, Supply Chain, and other stakeholders.
Escalates key issues, risks, and decisions to leadership with clear options and recommendations.
Prepares and delivers project updates to executive and site leadership, including dashboards, presentations, and written reports.

Requirements

Bachelor’s degree in engineering, science or relevant field required.
3+ years of engineering program/project management experience in biotechnology, pharmaceutical, or other regulated life sciences manufacturing environment is required.
Experience with facility buildouts and equipment CQV strongly preferred.
Experience leading capital or infrastructure projects involving construction, utilities, and equipment installation in cGMP or similarly regulated environments preferred.
Experience working with cross-functional teams, external design and construction partners, and multiple stakeholders in a matrixed organization preferred.
Hands-on experience with both traditional (Waterfall) and Agile or hybrid project management methodologies preferred.
PMP or other project management certification preferred.

Benefits

Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

project managementfacility buildoutsequipment commissioningqualification activitiescapital project managementrisk managementbudget managementCQV deliverablescGMP complianceconstruction management

Soft Skills

communicationleadershiporganizational skillscross-functional collaborationproblem-solvingstakeholder managementdecision-makingreportingpresentation skillsteam coordination

Certifications

PMPproject management certification