Senior Project Engineer

SHARP STERILE MANUFACTURING LLC -
Lee, MA

Quick Apply

Job Details

Full-time
$97,000 - $122,000 a year

Qualifications

Construction cost control
Technical documentation
Pharmaceutical regulatory compliance
GMP
Manufacturing facility experience
Data integrity and documentation
Schedule management
Bachelor's degree in engineering
Quality risk management
Utilities construction project management
Engineering project budget management
Cleanroom gowning procedures
Pharmaceutical company experience
Compliance documentation
Project management software
Managing projects
Productivity software
Manufacturing
Industrial plant projects
Project risk management
Project stakeholder communication
Pharmaceutical manufacturing facility experience
Stakeholder management

Full Job Description

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

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

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.

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

Regulatory Responsibilities

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.

Supervisory Responsibilities

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

Education

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related field) required
Master’s degree or professional certification (e.g., PMP) preferred

Experience

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

Physical Requirements

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

Quick Apply

Job Seeker Tools

Employer Tools

Browse

Stay Connected