Senior Specialist, Project Management

Senior Specialist, Project Management

The Senior Specialist, Project Management will lead production‑process capital improvement projects in a biopharmaceutical environment. The role focuses on process efficiency, adherence to product requirements, cost management, and return on investment.

• Develop, specify, and manage project scopes and deliverables according to Global and Site Engineering, Safety, and Quality requirements.
• Develop preliminary project schedules in MS Project and maintain schedules throughout the project life cycle.
• Create project budgets and forecasts, and track financial performance.
• Open and track Quality Change Requests related to project scopes.
• Open and track Safety Management of Change (MOCs) requests related to project scopes.
• Coordinate and manage Process Hazard Analysis execution and Action Plan completion.
• Coordinate and manage ergonomic, industrial hygiene, and other safety assessments and resulting Action Plans.
• Develop project intake documents to secure alignment for project activities.
• Attend and execute Equipment Vendor Factory Acceptance Testing and Site Acceptance Testing.
• Oversee contractors and consultants to deliver projects as agreed with customer groups.
• Develop URS, FRS, and DDS for small projects; manage development of these packages for larger projects.
• Review and approve URS, FRS, and DDS specifications developed by external providers.
• Lead project team meetings.
• Define and develop customer-supplied justification expectations.
• Issue purchase orders and change orders to suppliers.
• Monitor, verify, and approve supplier invoicing.
• Close out projects when complete and assign depreciation profiles in cooperation with Accounting and Finance.

• Work with customers to develop User Requirement Specifications for project and change control activities.
• Develop and execute, or contract out, commissioning, qualification, and validation protocols for testing of system changes and upgrades.
• Train user groups on efficient and effective use of system interfaces and required applications.
• Develop and maintain SOPs to support project deliverables.

• Develop and maintain Energy Control Procedures to support project deliverables.
• Manage development and use of job safety/hazard assessments by contractors during construction and by end users as projects are turned over.

• Bachelor's Degree in Engineering (Chemical, Biological Systems, or Biomedical Engineering preferred).
• 5+ years managing projects between $250K and $10M in a highly regulated industry (biotech, pharma, food, nuclear).
• Direct experience with commissioning, qualification, and validation of biotech equipment systems.
• Ability to drive a car and perform limited travel (5% or less).
• Excellent knowledge of industrial and construction safety (OSHA 10 required, OSHA 30 preferred).

• Proficiency with PC and common software (Excel, Word, Outlook, etc.).
• Advanced knowledge of MS Office and MS Project Professional.
• Ability to use handheld measuring devices.
• Capacity to sit, stand, and walk for 8+ hours per day.
• Ability to lift up to 50 lbs on a limited basis; climb stairs and ladders for equipment access.
• Capability to work in unconditioned spaces when required.

• Experience with project management tools such as Oracle Primavera, Planview, Eco Sys.
• Project spending and completion forecasting.
• Experience with financial management, including budget development and cost control.

Salary Range
$104,200 – $163,900

Benefits
Medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days.

EEO Statement
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.