Process Compliance Engineer – II (Associate) - MKVG

Title: Process Compliance Engineer – II (Associate) 
Duration: 12 months 
Location: West Point, PA 
Schedule: Onsite for initial training; hybrid (3 days onsite) post-training 

Job Description: 

Join a dynamic pharmaceutical manufacturing environment to support sterile operations within the West Point facility. As a Process Compliance Engineer, you will play a critical role in supporting GMP documentation, investigations, and continuous improvement initiatives. 

Key Responsibilities: 

• Author and revise GMP documentation including SOPs, batch records, change controls, and validation protocols 

• Support quality investigations, deviation analysis, and root cause assessments 

• Drive documentation updates and CAPA execution aligned with regulatory and internal standards 

• Provide floor-level operational support to troubleshoot equipment/process issues 

• Lead or support projects that enhance process efficiency, compliance, and safety 

• Collaborate cross-functionally with Quality Assurance, Manufacturing, and Engineering teams 

Qualifications: 

• Bachelor’s degree in Engineering, Science, or related discipline 

• 2–4 years’ experience in GMP-regulated or manufacturing environments (co-op experience acceptable) 

• Strong technical writing, attention to detail, and organizational skills 

• Demonstrated project coordination and stakeholder engagement 

Preferred Skills: 

• Experience in sterile manufacturing, vaccines, or biologics production 

• Familiarity with deviation and change control systems (e.g., TrackWise)