Validation Engineer

Validation EngineerThe Validation Engineer leads validation activities for assigned projects across the full lifecycle, from requirements definition through decommissioning. This role develops and maintains comprehensive validation documentation, drives protocol authoring and execution, and ensures systems, equipment, and processes comply with applicable regulatory and internal quality standards. The position is fully on-site and offers the opportunity to contribute directly to the manufacture of therapies that improve patient lives, while gaining career-defining experience in a complex, high-performing pharmaceutical environment.Responsibilities:Lead the validation effort for assigned projects, serving as the primary owner of validation activities from initial requirements through decommissioning.Develop, revise, and maintain validation documentation in accordance with established procedures, including validation plans and reports, specifications, risk assessments, traceability matrices, and decommissioning plans and reports.Author, execute, and generate reports for Design Review/Qualification, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation activities, as required for each project.Support commissioning and qualification activities to ensure systems, equipment, and processes are ready for validation execution.Attend Factory Acceptance Testing (FAT) and other project-related testing events as needed to support validation and qualification activities.Track all validation documentation associated with assigned projects, ensuring timely completion, accuracy, and proper approvals.Provide routine project status updates, including progress, risks, and issues, and escalate concerns to project managers when necessary.Identify, investigate, and document deviations or engineering changes encountered during validation activities, ensuring appropriate follow-up and resolution.Initiate, author, and support Change Controls, including assessing validation impact for proposed changes and ensuring alignment with quality and regulatory expectations.Utilize approved electronic systems, such as TIMS (HP ALM) and VeeVa (QualityDocs, VaultQuality), to create, revise, route, and approve validation and change control records.Ensure all validation deliverables comply with applicable Good Manufacturing Practice (GMP) requirements, FDA regulations, EU Annex 15 guidance, and internal procedures.Collaborate closely with engineers, validation specialists, quality professionals, and manufacturing teams to support cross-functional project execution and continuous improvement.Contribute to the upgrade of an existing manufacturing facility by supporting validation activities for equipment, utilities, and processes within the established operation.Essential Skills:Demonstrated experience in validation within a GMP-regulated pharmaceutical or manufacturing environment.Hands-on experience with validation of manufacturing equipment and process control systems.Ability to develop, author, execute, and report on IQ, OQ, PQ, and Process Validation protocols.Proficiency in creating and maintaining validation documentation, including validation plans, reports, specifications, risk assessments, and traceability matrices.Experience identifying, documenting, and investigating deviations and engineering changes during validation activities.Capability to initiate and support Change Controls, including assessing validation impact for proposed changes.Familiarity with regulatory and guidance requirements such as GMP, FDA expectations, and EU Annex 15.Ability to use electronic quality and validation systems such as TIMS (HP ALM) and VeeVa (QualityDocs, VaultQuality) for document and record management.Strong organizational skills to track multiple validation deliverables and provide clear project status updates.Effective communication skills to collaborate with cross-functional teams and present validation status, risks, and recommendations.Additional Skills & Qualifications:Experience with aseptic formulation and filling equipment validation.Background in validation of vision inspection systems used in pharmaceutical manufacturing.Exposure to assembly processes and related equipment within a regulated manufacturing environment.Interest in working on complex validation projects involving equipment qualification, utilities, process validation, cleaning validation, computerized systems validation, and commissioning support.Motivation to contribute to meaningful work that directly supports the manufacture of therapies for patients worldwide.Desire to work in an industry-leading environment focused on quality, operational excellence, and advanced manufacturing technologies.Interest in collaborating with high-performing, cross-functional teams of engineers, validation specialists, quality professionals, and manufacturing leaders.Ambition to build long-term career growth through exposure to future capital projects, operational readiness initiatives, and ongoing manufacturing expansion.Work Environment:This position is fully on-site at a pharmaceutical manufacturing facility in Clayton, North Carolina, five days per week. The role follows normal business hours, with the flexibility to work occasional overtime, evenings, and weekends, particularly during larger projects or plant shutdowns. The work takes place in an established, older facility undergoing upgrade rather than a new capital project, offering exposure to modernization efforts within an existing operation. The environment is highly regulated and quality-focused, with access to advanced manufacturing technologies and electronic quality systems such as TIMS (HP ALM) and VeeVa (QualityDocs, VaultQuality). You will work closely with experienced engineering, validation, quality, and manufacturing teams in a collaborative, professional setting that emphasizes technical excellence, continuous improvement, and a strong commitment to ensuring safe and reliable product supply.Job Type & Location:This is a Contract position based out of Clayton, NC.Pay and Benefits:The pay range for this position is $60.00 - $90.00/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)