Validation Specialist

Job Description

Job Description

Job Title: Validation Specialist

Job Description

The QC Inspection Specialist (QMCS / Validation Specialist) supports computerized system validations and broader validation activities across pharmaceutical manufacturing operations. Working closely with Quality, Manufacturing, Engineering, Facilities, and Operations teams, this role ensures equipment, systems, and processes comply with current Good Manufacturing Practices (cGMP) in a regulated environment. It is well suited for professionals in computer science, software, engineering, chemistry, or validation who enjoy a fast-paced manufacturing setting and are motivated to drive compliance, quality, and operational excellence.

Responsibilities

• Manage the lifecycle of computerized systems in a regulated pharmaceutical manufacturing environment, ensuring ongoing compliance and validated state.
• Lead and support computerized system validation (CSV) activities for manufacturing, laboratory, and automation systems.
• Author, review, and execute IQ/OQ/PQ protocols and other validation documentation for equipment, systems, and processes.
• Develop, implement, and maintain validation procedures, policies, and standards aligned with cGMP requirements.
• Support equipment qualification, system implementation, and change control activities, including documentation and execution.
• Conduct risk assessments, gap analyses, and traceability exercises to identify and mitigate validation and compliance risks.
• Review, revise, and update standard operating procedures (SOPs) and manufacturing process documentation to reflect validated states and regulatory expectations.
• Collaborate with Quality, Engineering, Manufacturing, Facilities, and Operations teams to plan, coordinate, and execute validation projects.
• Support CAPA investigations by contributing to root cause analysis, defining corrective and preventive actions, and maintaining validated status of systems and equipment.
• Assist with internal and external audits and inspections by preparing documentation, addressing findings, and supporting compliance initiatives.
• Prepare clear and comprehensive validation reports, discrepancy reports, and technical documentation to support regulatory and quality requirements.
• Contribute to visual inspection and QC activities related to production and laboratory processes, ensuring product and process quality.
• Promote quality assurance best practices across production, laboratory, and inspection activities, reinforcing adherence to cGMP and internal standards.

Essential Skills

• Bachelor's degree in Engineering, Science, Computer Science, Software Engineering, Chemistry, or a closely related field.
• At least 5 years of validation experience in a pharmaceutical or manufacturing environment.
• Demonstrated experience working within cGMP-regulated environments and applying regulatory guidance to daily operations.
• Hands-on experience with computerized system validations (CSV) in manufacturing or laboratory settings.
• Strong technical writing and documentation skills, including authoring protocols, reports, and SOPs.
• Proficiency with Microsoft Office applications for documentation, data analysis, and reporting.
• Experience working with quality assurance processes, QC inspection, SOP development, and production support in a regulated environment.

Additional Skills & Qualifications

• Experience validating laboratory or manufacturing equipment, including automation systems.
• Knowledge and practical experience with IQ/OQ/PQ execution for equipment and computerized systems.
• Familiarity with CAPA, Change Control, and Risk Assessment processes in a pharmaceutical or manufacturing context.
• Experience with pharmaceutical manufacturing equipment and related laboratory systems.
• Strong project coordination skills, including planning, prioritizing, and tracking validation activities.
• Effective stakeholder management skills with the ability to collaborate across Quality, Engineering, Manufacturing, Facilities, and Operations.
• Exposure to visual inspection, laboratory QC, and production processes in a pharmaceutical setting.

Work Environment

This role operates within a pharmaceutical manufacturing environment that produces a wide range of biological extracts for diagnostic testing and therapeutic treatment of allergy, as well as supplies to support immunotherapy practices. The setting is highly regulated, cGMP-driven, and quality-focused, with close collaboration among Quality, Manufacturing, Engineering, Facilities, and Operations teams. Work involves interaction with laboratory and manufacturing equipment, computerized systems, and automation technologies. Permanent employees may be eligible for benefits such as medical and dental coverage for the employee, retirement savings options, and discounted gym memberships. The environment emphasizes compliance, safety, and continuous improvement, with expectations for professional attire appropriate to a pharmaceutical manufacturing and laboratory setting.

This is a Contract to Hire position based out of Oklahoma City, OK.

The pay range for this position is $28.00 - $32.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

This is a fully onsite position in Oklahoma City,OK.

This position is anticipated to close on Aug 25, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.