Validation Engineering

Validation SpecialistThe 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.ResponsibilitiesManage 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 SkillsBachelor'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 & QualificationsExperience 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 EnvironmentThis 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.Job Type & LocationThis is a Contract to Hire position based out of Oklahoma City, OK.Pay and BenefitsThe 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)Workplace TypeThis is a fully onsite position in Oklahoma City, OK.Application DeadlineThis position is anticipated to close on Aug 25, 2026.