6430 - GMP Change Control Specialist / Project Engineer

United States·Kalamazoomid

EngineeringProject Engineer

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Quick Summary

Key Responsibilities

Initiate, coordinate, and manage GMP change controls in support of manufacturing, engineering, facilities, utilities, and quality initiatives Assess proposed changes for regulatory, quality,

Requirements Summary

Initiate, coordinate, and manage GMP change controls in support of manufacturing, engineering, facilities, utilities, and quality initiatives Assess proposed changes for regulatory, quality,

Technical Tools

EngineeringProject Engineer

Description

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

Responsibilities

~1 min read

→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

Requirements

~1 min read

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

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.

National (US) Range

$70,491—$86,276 USD

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