locations NZL - Wellington - Upper Hutt (Whakatiki) time type Full time posted on Posted 11 Days Ago job requisition id R280884 Job Description Validation Engineer To be based at our manufacturing site in Upper Hutt, New Zealand Salary Bracket (dependant on experience) NZD $80,000 to $120,000 Base + Bonus Working hours: 40 hours per week Opportunity 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 p ackage The 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 DO Ensures 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: Design Qualification Operational Qualification Performance Qualification Process Validation Cleaning Validation Completing all assigned re-validation tests in accordance with established procedures. Includes re-validation of: Temperature controlled rooms Incubators Laminar air flow units / biohazards Room classification Isolators Autoclaves WHAT YOU MUST HAVE Hold a relevant tertiary qualification in Engineering or Science related discipline Demonstrate prior validation experience working on equipment, facilities &/or utilities Experience in biotechnology or the pharmaceutical industry is highly regarded Have a solid understanding and working experience within GXP Hold the ability to work well under pressure and achieve results often to tight deadlines Have excellent communication and interpersonal skills with the ability to inspire others towards a common goal Take a proactive approach to your own learning and development and find creative ways to solve problems Demonstrate strong documentation skills including the creation and implementation of protocols You 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 EXPECT Be part of a leading global organisation with a long-standing history in NZ Opportunity to work on exciting project s 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. Search 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) Job Description Validation Engineer (Projects) Fixed-Term Contract until 31st December 2025 To be based at our manufacturing site in Upper Hutt, New Zealand Salary Bracket (dependant on experience) NZD $80,000 to $120,000 Base + Bonus Working hours: 40 hours per week Opportunity 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 p ackage The 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 DO Ensures 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 studies Design Qualification Installation Qualification Operational Qualification Performance Qualification Process Validation Cleaning Validation Completing all assigned re-validation tests in accordance with established procedures. Includes re-validation of: Temperature controlled rooms Incubators Laminar air flow units / biohazards Room classification Isolators Autoclaves Steam sterilized vessels WHAT YOU MUST HAVE Hold a relevant tertiary qualification in Engineering or Science related discipline Demonstrate prior validation experience working on equipment, facilities &/or utilities Experience in biotechnology or the pharmaceutical industry is highly regarded Have a solid understanding and working experience within GXP Hold the ability to work well under pressure and achieve results often to tight deadlines Have excellent communication and interpersonal skills with the ability to inspire others towards a common goal Take a proactive approach to your own learning and development and find creative ways to solve problems Demonstrate strong documentation skills including the creation and implementation of protocols You 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 EXPECT Be part of a leading global organisation with a long-standing history in NZ Opportunity to work on exciting project s 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 HERE Current Contingent Workers apply HERE Search 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 relocation VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. #J-18808-Ljbffr
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