6430 - GMP Change Control Specialist / Project Engineer

Job Overview

We are seeking a Change Control Project Engineer to support change management activities within a GMP-regulated pharmaceutical manufacturing environment.

Project Engineer Responsibilities

• Initiate, coordinate, and manage GMP change controls in support of manufacturing, engineering, facilities, utilities, and quality initiatives
• Assess proposed changes for regulatory, quality, validation, and operational impact while ensuring compliance with internal procedures and cGMP requirements
• Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and other cross-functional teams to drive change control activities through completion
• Track change control progress, facilitate timely approvals, and ensure all required documentation and supporting deliverables are completed
• Support risk assessments, implementation planning, and change effectiveness activities associated with engineering and manufacturing projects
• Maintain accurate documentation and provide status updates to stakeholders while ensuring changes are implemented in accordance with applicable quality systems

Job Requirements

• Bachelor's degree in Engineering or a related technical discipline (Mechanical, Chemical, Biomedical, Industrial, or similar preferred)
• 1–3 years of experience supporting GMP change control/change management activities within a pharmaceutical, biotechnology, or life sciences manufacturing environment
• Working knowledge of cGMP regulations, quality systems, and pharmaceutical manufacturing operations
• Experience coordinating cross-functional projects and managing multiple priorities in a regulated environment
• Strong organizational, communication, and problem-solving skills
• Proactive attitude with a willingness to learn
• Proficiency with Microsoft Office applications

Company Culture Guidelines & Values

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement