- The Validation Engineer supports validation activities related to facility, manufacturing process, cleaning process, equipment, critical utilities & computerized systems.
- These will encompass new facility/equipment/process, process & equipment changes & periodic requalification/revalidation.
- The incumbent prepares validation plans, protocols, test scripts & reports throughout all stages of validation lifecycle.
- Furthermore, the incumbent will be responsible for coordination & execution of validation activities & be expected to play a key role in developing & driving risk based validation approach during essential stages of product lifecycle including process design/control strategy development, technology transfer, equipment/utilities commissioning & qualification (C&Q), process performance qualification (PPQ), continued process verification (CPV), process control/risk management, & product decommissioning.
- Perform qualification of manufacturing equipment, facility & utility systems (including CIP/SIP qualification), cleaning validation, & process validation. Scope of responsibilities includes drafting of qualification protocols & summary reports, field execution, & data analysis.
- As needed coordinate & provide directions to contract personnel performing validation activities.
- Support the development & execution of FATs, SATs, DQ, IQ, OQ, PQ, & other relevant life cycle documents leveraged to support validation effort.
- Support the development & update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports.
- Support cleaning & sterilization (including CIP/SIP, manual cleaning, steam sterilization & dry heat depyrogenation) development activities.
- Support periodic requalification & revalidation effort.
- Work independently & directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC & QA.
- Support gap assessment/closure, corrective actions, & compliance remediation related to Validation
- Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation & Process Validation.
- Familiar with applicable domestic & international GMP regulations impacting validation requirements (e.g. 21 CFR 210).
- Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, ISO 14971, ASTM E2500, & applicable PDA Technical Reports).
- Experience with customer & regulatory inspection.
- Strong understanding of quality risk management principles, including best practice in risk based C&Q approach.
- Hands on validation experience in developing validation documentation & field execution.
- Project Management experience is a plus
- Familiarity & demonstrated knowledge of biologics manufacturing processes, including fermentation, purification & bulk filling processes.
- Ability to work independently in a matrix team environment, influence team decisions & exercise sound judgement in determining compliant & robust validation approach.
- Ability to multi-task with demonstrated track records in meeting deliverable timelines.
- Must demonstrate the ability to think critically & analytically with acumen for trouble-shooting & problem solving.
- Good interpersonal skills & accountable with excellent verbal & written communication skills.
- Ability to function effectively & independently in a fast-paced & dynamic environment.
Self-motivated & willing to tackle assignments & development opportunities outside of job scope as needed.
Ability to interpret engineering & facility drawings such as facility layouts, blueprints, material/process flow diagrams & equipment P&IDs.
- Expert Microsoft Word / PowerPoint & Intermediate Microsoft Excel skills are required.
- Understanding of basic statistics, acceptance sampling & familiar with statistics software such as Minitab & JMP
- Strong team player
- Hands on experience with facility/equipment/utility qualification, cleaning validation, process validation & sterilization validation experience (steam sterilization & dry heat depyrogenation) in GMP environment is required.
- Hands on experience with CIP/SIP cycle development & qualification is required.
- Automation & Part 11 validation experience is a plus
Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus.
English fluent in speaking / writing
Minimum 5+ years of relevant validation experience in regulated industry
The engineer is expected to be proficient in at least 2 of 7 validation core expertise
Validation Core Expertise:
- Facility Qualification
- Equipment Qualification
- Utilities Qualification
- Cleaning Validation
- Process Validation
- Sterilization Validation
- Computerized System Validation
- EQUIPMENT VALIDATION
- SYSTEM VALIDATION
- PROCESS VALIDATION