The Senior Validation Engineer supports validation activities related to facility, manufacturing process, cleaning process, equipment, critical utilities, and computerized systems.
These will encompass new facility/equipment/process, process and equipment changes, and periodic requalification/revalidation.
The incumbent prepares validation plans, protocols, test scripts and reports throughout all stages of validation lifecycle.
The incumbent will be responsible for coordination and execution of validation activities and be expected to play a key role in developing and 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, and product decommissioning.
Perform qualification of manufacturing equipment, facility and utility systems (including CIP/SIP qualification), cleaning validation, and process validation. Scope of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis.
As needed coordinate and provide directions to contract personnel performing validation activities.
Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort.
Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports.
Support cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization, and dry heat depyrogenation) development activities.
Support periodic requalification and revalidation effort.
Work independently and directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA..
Support gap assessment/closure, corrective actions, and compliance remediation related to Validation.
As needed represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections.
Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus.
Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, and Process Validation.
Familiar with applicable domestic and 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, and applicable PDA Technical Reports).
Experience with customer and 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 and 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.
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 aligned with Grifols Corporate Values.
Hands on experience with facility/equipment/utility qualification, cleaning validation, process validation & sterilization validation (steam sterilization & dry heat depyrogenation) in GMP environment is required.
Hands on experience with CIP/SIP cycle development & qualification is required.
Minimum 7+ years of relevant validation experience in regulated industry.
The engineer is expected to be proficient in at least 4 of 7 validation core expertise.
Validation Core Expertise:
Computerized System Validation
Associated topics: bio, bioinformatic, biology, biomedical engineer, enzyme, hereditary, metabolic, neuro, neuroscience, parenteral