Change Control Specialist

Description

We are seeking a detail-oriented and proactive Change Control Specialist to support the Engineering Compliance Group at our client's bio-pharmaceutical manufacturing facility. This role is critical to ensuring that all engineering-related changes are properly documented, assessed, and implemented in compliance with regulatory requirements, internal quality standards, and Good Manufacturing Practices (GMP). Key Responsibilities : Coordinate and manage the change control process for engineering projects, equipment modifications, and facility upgrades. Review and assess change control requests for completeness, accuracy, and regulatory impact. Collaborate with cross-functional teams (Engineering, Quality Assurance, Validation, Manufacturing) to ensure timely and compliant execution of changes. Maintain accurate records of change control documentation in electronic systems (e.g., TrackWise, Veeva, or equivalent). Ensure changes are evaluated for impact on validated systems, regulatory filings, and GMP compliance. Support internal and external audits by providing documentation and responding to inquiries related to change controls. Monitor and report on change control metrics and KPIs to identify trends and opportunities for process improvement. Assist in training engineering and technical staff on change control procedures and compliance expectations.

Skills

change control, GMP, engineering, Compliance, veeva vault, Document control

Top Skills Details

change control,GMP,engineering,Compliance,veeva vault

Additional Skills & Qualifications

Familiarity with validation protocols and regulatory submission processes. Experience supporting capital projects or facility expansions. Knowledge of risk assessment methodologies and impact analysis.

Experience Level

Intermediate Level

Pay and Benefits

The pay range for this position is $30.00 - $50.00 / hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off / Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Raleigh,NC.

Application Deadline

This position is anticipated to close on Sep 30, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.