"Alerted.org

Job Title: Change Control SpecialistJob Description

We are seeking a detail-oriented and proactive Change Control Specialist to support the Engineering Compliance Group at a 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).

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 such as Engineering, Quality Assurance, Validation, and Manufacturing to ensure timely and compliant execution of changes.

+ Maintain accurate records of change control documentation in electronic systems like 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.

Essential Skills

+ Proficiency in change control processes and Good Manufacturing Practices (GMP).

+ Experience with Veeva Vault and document control systems.

+ Bachelor’s degree in Engineering, Life Sciences, or a related field, or equivalent experience.

+ 3+ years of experience with initiating change controls in a pharmaceutical GMP environment.

+ Technical writing skills.

+ Experience in process engineering.

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.

Work Environment

The position is based in a pharmaceutical manufacturing office environment. The work schedule is Monday to Friday, 8:00 AM to 4:30 PM, totaling a 40-hour work week. Flexibility is required based on business needs and must be approved by the sponsor. The team is highly matrix-oriented, encouraging interaction across engineering, compliance, quality, and capital expenditure sectors. This role offers the opportunity to engage with new product pipelines and contribute to new area developments at the site. With numerous investments being made at the facility, there is ample opportunity for growth. The team is diverse, and the management is supportive. The contract is initially for 12 months, with potential extensions based on budget and business needs, up to a maximum tenure of 4 years.

Job Type & Location

This is a Contract position based out of Sanford, North Carolina.

Pay and Benefits

The pay range for this position is $50.00 - $80.00/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 hybrid position in Sanford,NC.

Application Deadline

This position is anticipated to close on Oct 17, 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 [email protected] (%[email protected]) for other accommodation options.