GMP Change Control Project Engineer — On‑Site

Veristainc; Kalamazoo (MI); On-site; USD 70,491 - 86,276; Full time

Benefits offered by this job

On-site role in Kalamazoo

Competitive pay and incentive programs

Company-paid Life, Short-Term, andLong

Medical, Dental & Vision insurances

401(k) with employer matching

Job summary

Verista in Kalamazoo, MI is seeking a Change Control Project Engineer to support GMP change controls across manufacturing, facilities, utilities and process improvements. You will collaborate with Engineering, Manufacturing, Quality Assurance and Validation to drive change control activities through completion.

The ideal candidate has 1–3 years of life sciences change control experience and a strong engineering background, with a proactive, organized approach and proficiency in Microsoft Office

Qualifications

• 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.

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.

Skills

Cross-functional coordination

Organizational skills

Communication skills

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Microsoft Office applications

Job description

Verista in Kalamazoo, MI is seeking a Change Control Project Engineer to support GMP change controls across manufacturing, facilities, utilities and process improvements. You will collaborate with Engineering, Manufacturing, Quality Assurance and Validation to drive change control activities through completion.

The ideal candidate has 1–3 years of life sciences change control experience and a strong engineering background, with a proactive, organized approach and proficiency in Microsoft Office