Senior Project Engineer
Berkshire Sterile Manufacturing
Position Summary The Senior Project Engineer is responsible for leading and executing capital projects with a regulated pharmaceutical manufacturing environment. This role ensures projects are delivered safely, on time, within budget, and in compliance with cGMP and regulatory requirements. The position requires strong technical expertise, cross functional leadership, and the ability to manage complex projects from concept through commissioning and qualification.
Duties and Responsibilities
Duties and Responsibilities
- Lead capital projects for initiation through design, procurement, construction, commissioning, qualification, and closeout.
- Manage project scope, schedule, budget, and resources to ensure successful delivery of projects.
- Develop and maintain project documentation including User Requirement Specifications (URS), Functional Specifications, Design Specifications, and validation documentation.
- Coordinate cross-functional teams including Engineering, Manufacturing, Quality, Validation, and Supply Chain.
- Oversee contractors, vendors, and external engineering firms to ensure compliance with project requirements and site standards.
- Identify project risks and implement mitigation strategies to minimize impact to schedule, cost, and compliance.
- Ensure alignment with regulatory requirements including FDA, EU GMP Annex 1, and internal quality systems.
- Participate in change control, deviation investigations, CAPAs, and risk assessments associated with projects.
- Support commissioning and qualification activities including FAT/SAT, IQ/OQ/PQ execution and documentation.
- Provide technical expertise in facilities, utilities, equipment, and process systems.
- Drive continuous improvement initiatives related to project execution, equipment performance, and operational efficiency
- Develop and present project updates and metrics to senior leadership
- Support capital planning, budgeting, and long-term site master planning activities
- Ensure adherence to safety standards and promote a strong safety culture throughout project execution
- Other duties as assigned
- Strong knowledge of pharmaceutical manufacturing systems, utilities, and equipment
- In-depth understanding of cGMP, regulatory requirements, and validation practices.
- Project management expertise including scheduling, cost control, and risk management
- Ability to develop and review engineering and validation documentation
- Strong problem-solving and analytical skills
- Excellent communication and leadership abilities
- Ability to manage multiple projects simultaneously in a fast-paced environment
- Proficiency with project management tools and Microsoft Office Suite
- Experience with change management and quality systems (e.g., MasterControl) preferred
- Ability to influence stakeholders and drive decision-making
- Maintain working knowledge of 21 CFR 210/211, EU Annex 1, and other applicable regulatory requirements
- Ensure all project activities comply with cGMP, data integrity, and company SOPs
- Support audit readiness and participate in regulatory inspections as required
- Ensure proper documentation, traceability, and compliance for all engineering and project activities.
- Provide technical leadership and mentorship to junior engineers and project team members
- Coordinate internal and external project resources without direct supervisory authority
- Influence cross-functional teams to achieve project objectives and timelines
- Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related field) required
- Master's degree or professional certification (e.g., PMP) preferred
- Minimum ten (10) years of experience managing capital projects
- Minimum five (5) years of experience in pharmaceutical or regulated GMP environments
- Demonstrated experience managing complex facility, utility, and/or equipment projects
- Proven track record of delivering projects on time and within budget
- Experience with aseptic processing, cleanroom environments, and/or sterile manufacturing preferred
- Ability to sit or stand for prolonged periods of time
- Ability to lift and carry materials weighing as much as 50lbs
- Ability to stand and walk in manufacturing and construction environments as required
- Ability to meet cleanroom gowning requirements.
- Ability to travel between facilities or vendor sites as needed
Vacancy posted 3 days ago
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