Validation Specialist

Actalent is seeking a Validation Specialist to support computerized system validations and broader validation activities in a pharmaceutical manufacturing environment. This role collaborates closely with Quality, Manufacturing, Engineering, Facilities, and Operations teams to ensure compliance with current Good Manufacturing Practices (cGMP). Ideal candidates have a background in computer science, software, engineering, chemistry, or validation and thrive in a fast-paced, regulated setting.

About the role

This position operates within a highly regulated, cGMP-driven pharmaceutical manufacturing environment that produces biological extracts for diagnostic testing, allergy treatment, and immunotherapy supplies. The role emphasizes compliance, safety, and continuous improvement, with close collaboration across Quality, Manufacturing, Engineering, Facilities, and Operations teams. Work involves interaction with laboratory and manufacturing equipment, computerized systems, and automation technologies.

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.

Requirements

• 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.

Skills

• 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.

Pay

The pay range for this position is $28.00 - $32.00 per hour. Individual compensation within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

If eligible, benefits for this temporary role may include:

• Medical, dental, and vision coverage.
• Critical Illness, Accident, and Hospital insurance.
• 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).

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

Schedule

This is a Contract to Hire position based in Oklahoma City, OK. The role is fully onsite.