Job DescriptionValidation Engineer (Projects) Fixed-Term Contract until 31st December 2025To be based at our manufacturing site in Upper Hutt, New ZealandSalary Bracket (dependant on experience) NZD $80,000 to $120,000 Base + BonusWorking hours 40 hours per weekOpportunity to bring your knowledge and implement your Validation and Data Integrity skills whilst being a part of our collaborative Validation Team Competitive Renumeration and Benefits packageThe primary responsibility of the Validation Engineer is to support the site by ensuring all equipment qualification of new equipment and routine re-validation of existing rooms, equipment and processes is performed to maximise the use of company assets while all GMP, corporate and legislative compliance requirements are met.The Validation Engineer sits within the Engineering organization and reports to the Validation Manager, New Zealand.What You Will DoEnsures all equipment qualification work is carried out to meet the site requirements.Manage the planning, execution and documentation of qualification studies on new and legacy equipment.Complete all assigned re-validation tests in accordance with established procedures.Write validation protocols and summary reports for complex items of equipment (e.g. autoclaves, fermenters).Accurately record data and observations on test execution worksheets in accordance with Good Documentation Practices.Complete all ancillary documentation (eg deviation reports).After one year, you will be supporting the manufacturing site to maximise the use of company assets and complete the qualification studies and validation tests to the agreed schedule.Managing the planning, execution and documentation of qualification studies on new and legacy equipment. Includes Commissioning studiesDesign QualificationInstallation QualificationOperational QualificationPerformance QualificationProcess ValidationCleaning ValidationCompleting all assigned re-validation tests in accordance with established procedures. Includes re-validation of Temperature controlled roomsIncubatorsLaminar air flow units / biohazardsRoom classificationIsolatorsAutoclavesSteam sterilized vesselsWhat You Must HaveHold a relevant tertiary qualification in Engineering or Science related disciplineDemonstrate prior validation experience working on equipment, facilities &/or utilitiesExperience in biotechnology or the pharmaceutical industry is highly regardedHave a solid understanding and working experience within GXPHold the ability to work well under pressure and achieve results often to tight deadlinesHave excellent communication and interpersonal skills with the ability to inspire others towards a common goalTake a proactive approach to your own learning and development and find creative ways to solve problemsDemonstrate strong documentation skills including the creation and implementation of protocolsYou may be an experienced Validation Engineer who is looking to join an innovative biopharma and utilise your skills and experience on an exciting project. Solid knowledge & prior experience with "hands on" Validation Engineering, ideally with experience using Validation Equipment.What You Can ExpectBe part of a leading global organisation with a long-standing history in NZOpportunity to work on exciting projects whilst being part of a friendly, supportive and dedicated team.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status Project Temps (Fixed Term)Relocation No relocationVISA Sponsorship Travel RequirementsFlexible Work Arrangements Not ApplicableShift Valid Driving License Hazardous Material(s) Requisition ID R280884#J-18808-Ljbffr
