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.

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