Equipment Validation Engineer / Validation Specialist

ph3Company: /h3 pWe are partnering with a leading organization in the pharmaceutical or biotech manufacturing sector, dedicated to ensuring high standards of quality and compliance within their production processes. Their technical department supports both new production lines and ongoing operations, emphasizing continuous improvement and adherence to regulatory requirements. /p h3Job Description: /h3 pWe are looking for an experienced Equipment Validation Engineer / Validation Specialist to join the Technical Support team, with a primary focus on equipment and automation validation. The role combines technical validation activities with quality documentation review, risk management and engineering support. The successful candidate will work independently, manage multiple assignments and provide specialist expertise within a relatively junior team. /p h3Responsibilities: /h3 ul liExecute and support equipment and automation validation activities for existing production equipment. /li liReview and approve validation documentation to ensure GMP, corporate, site and regulatory requirements are met. /li liProvide QA and quality engineering support for validation activities, testing strategies and investigations. /li liSupport Quality Risk Management activities, including risk assessments, pFMEA and QRAES. /li liReview and approve technical changes to equipment, parameters and Maintenance Engineering procedures. /li liPerform quality review of technical change controls and ensure required assessments are complete. /li liProvide guidance to Operations and Technical teams on quality policies, standards and procedures. /li liSupport validation-related investigations, Nonconformances, CAPAs and change controls. /li liEnsure validated systems and equipment remain compliant and properly documented. /li liManage multiple assignments independently and deliver quality objectives according to project requirements. /li /ul h3Requirements: /h3 ul liMaster’s degree in Engineering, Pharmaceutical Sciences, Process Technology or equivalent. /li liMinimum 5 years of professional experience in a GMP-regulated environment. /li liStrong experience in Equipment and Automation Validation. /li liProven knowledge of GMP, equipment validation and automation/IS validation. /li liExperience with Annex 11 and 21 CFR Part 11. /li liExperience with Quality Risk Management tools such as FMEA. /li liExperience reviewing validation and technical documentation from a quality perspective. /li liExperience with Change Control, Nonconformances, CAPAs and quality investigations is preferred. /li liExperience with statistical tools for activities such as sampling plans and hypothesis testing is preferred. /li liStrong analytical, organisational and documentation skills. /li liExcellent attention to detail and communication skills. /li liAbility to work independently with minimal supervision and manage multiple assignments. /li liStrong risk-based decision-making skills and ability to work effectively with Technical, Engineering, Operations and Quality teams. /li /ul h3Other Information: /h3 ul liThe role is hybrid, requiring at least 3 days per week onsite, ideally within an hour’s commute—relocation candidates are welcome. /li liThis is a 12-month contract with a strong possibility of extension, seeking long-term commitment. /li liStart date is flexible; candidates with a two-month notice period are encouraged to apply. /li liThe position offers a competitive pay rate, open for discussion based on experience. /li /ul /p #J-18808-Ljbffr