Validation Engineer

Responsibilities

• Generate and review validation study documentation including validation plans, change controls, protocols, requirements specifications, asset induction requests, commissioning documentation, final reports and addenda while ensuring compliance with cGMP requirements.
• Execute validation studies in support of engineering, manufacturing, process development, facilities, IT, quality control, and quality assurance.
• Manage or support the validation program.
• Suggests, develops and/or implements improvements to the program to ensure it maintains compliance with current regulatory and industry expectations.
• Support validation deliverables related to Equipment, Instruments, Facilities, Utilities, Cleaning, Computerized Systems and ongoing validations, as needed.
• Generate, revise and execute validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 Annex 15, GAMP and other regulatory and industry standard requirements as deemed necessary.
• Support Engineering (ENG), Facilities (FAC), Manufacturing (MFG), Process Development (PD), Quality Control (QC), Quality Assurance (QA) and Information Technology (IT) with validation activities.
• Generate and revise documentation including, but not limited to, plans, risk assessments, traceability matrices, policies, procedures, equipment characterization reports, summary reports, specification documents and vendor qualification documents for validation studies ensuring compliance with QA and cGMP systems.
• Generate and revise documentation including, but not limited to, plans, risk assessments, traceability matrices, policies, procedures, equipment characterization reports, summary reports, specification documents and vendor qualification documents for validation studies ensuring compliance with QA and cGMP systems.
• Generate and execute validation protocols for equipment, instruments, utilities, and control systems through commissioning, URS, Software Acceptance Testing (SAT), IQ, OQ, PQ and cleaning phases.
• Responsible for ongoing validation efforts of systems including Controlled Temperature Units (CTUs), Autoclaves, Lyophilizers, QC Glasswashers, Periodic Review
• Generate data and reports for the periodic review and/or periodic monitoring programs.
• Participate in both factory and site acceptance testing for new manufacturing and engineering equipment.
• Support facility qualification of classified environments.
• Aid in spreadsheets validation activities.
• Support the generation and execution of cleaning validation support activities, such as: sprayball coverage testing, cycle development studies, equipment characterization reports, and equipment sampling SOPs.
• Manage, schedule, and/or support laboratory-based cleaning validation studies, including but not limited to method validations and surface recovery studies (i.e. worst-case soil studies).
• Support Manufacturing, Engineering, Quality Assurance (QA), and Quality Control (QC) to evaluate and resolve equipment cleaning issues and failures and to address any cleaning or cleaning validation related activities.
• Resolve CAPA’s, nonconformances, protocol incidents, and change controls related to validation.
• May serve as a validation subject matter expert for client and regulatory audits.
• May be responsible for attending client meetings as an engineering representative for purposes of addressing validation topics.

Qualifications

• Bachelor's Degree (B.S.) or equivalent in engineering or life sciences.
• +1 years relevant experience.
• Strong quality orientation, excellent communication skills, ability to work in a fast-paced team environment, high attention to detail and high ethical standards.