6430 - GMP Change Control Specialist / Project Engineer
Description
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
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
Job Overview: We are seeking a Change Control Project Engineer to support change management activities within a GMP-regulated pharmaceutical manufacturing environment. This individual will be responsible for coordinating and executing change controls that support manufacturing, facilities, equipment, utilities, and process improvements while ensuring compliance with cGMP requirements. The ideal candidate has 1–3 years of experience managing change requests in the life sciences industry and possesses a strong engineering background.
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
This is a 100% on-site role in Kalamazoo, MI. Local candidates only.
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
Benefits
Why Choose Verista?
- 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
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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For more information about our company, please visit us at Verista.com