Senior Project Engineer

SHARP STERILE MANUFACTURING LLC•Lee, MA

8d•$97,000 - $122,000

About The Position

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.

Requirements

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
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

Nice To Haves

Experience with change management and quality systems (e.g., MasterControl) preferred
Master’s degree or professional certification (e.g., PMP) preferred
Experience with aseptic processing, cleanroom environments, and/or sterile manufacturing preferred

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