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Jobs or company...

Equipment Mechanical Engineer

Salary undisclosed
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About No deviationAt No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development - empowering our team members to grow personally and professionally.Position OverviewWe are looking for Equipment Mechanical Engineer to support the operation, maintenance, and reliability of biotechnology process equipment and systems. This role requires hands-on troubleshooting, technical assessments, and continuous improvement of equipment reliability within a GMP-regulated pharmaceutical environment.Key Responsibilities
  • Ensure the operation and reliability of biotechnology process equipment.
  • Troubleshoot equipment failures and malfunctions, providing technical assessments and corrective actions during normal and after-hours when required.
  • Develop, implement, and optimize preventive maintenance strategies, including job plan creation and datasheet development in systems.
  • Apply Operational Excellence and Lean Maintenance principles to drive continuous improvement initiatives.
  • Investigate deviations, develop corrective and preventive actions (CAPA), and implement change controls in a timely and compliant manner.
  • Conduct process equipment periodic reviews, including data integrity and security assessments.
  • Collect, analyze, and present data for operational issues and engineering projects of varying complexity.
  • Lead or support engineering projects within schedule, budget, and quality constraints.
  • Manage commissioning and qualification activities such as FAT, SAT, automation checkouts, IQ, OQ, PQ, and ensure asset, preventive maintenance, and spare parts creation for new process equipment.
  • Participate in system walk-downs, ensure closure of punch list items, and facilitate smooth transition of systems from project to operations.
  • Provide timely support for client inquiries during normal working hours and after-hours, if required.
  • Ensure qualified and experienced personnel are placed on-site for durations based on client needs. Any change in assigned personnel will require client approval.
  • Participate in periodic service level performance reviews based on agreed KPIs with the client.
  • Proactively recommend continuous improvement initiatives, including cost reduction and technical enhancements to optimize equipment performance.
Required Qualifications
  • Degree/Diploma in Mechanical Engineering or a related field.
  • 3-5 years of experience in process equipment maintenance, troubleshooting, and reliability within a biotechnology, pharmaceutical, or GMP-regulated environment.
  • Strong expertise in biotech process equipment and single-use systems.
  • Hands-on knowledge of equipment qualification protocols (FAT, SAT, IQ, OQ, PQ).
  • Understanding of Operational Excellence (Lean, Six Sigma) principles.
  • Strong problem-solving skills and ability to work independently or within a team.
  • Excellent communication skills for effective collaboration with cross-functional teams and stakeholders.
Why join us?
  • Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
  • Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
  • Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
  • Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
  • Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to applyAre you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!Please submit your resume, outlining your qualifications and experience relevant to the role, here.
About No deviationAt No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development - empowering our team members to grow personally and professionally.Position OverviewWe are looking for Equipment Mechanical Engineer to support the operation, maintenance, and reliability of biotechnology process equipment and systems. This role requires hands-on troubleshooting, technical assessments, and continuous improvement of equipment reliability within a GMP-regulated pharmaceutical environment.Key Responsibilities
  • Ensure the operation and reliability of biotechnology process equipment.
  • Troubleshoot equipment failures and malfunctions, providing technical assessments and corrective actions during normal and after-hours when required.
  • Develop, implement, and optimize preventive maintenance strategies, including job plan creation and datasheet development in systems.
  • Apply Operational Excellence and Lean Maintenance principles to drive continuous improvement initiatives.
  • Investigate deviations, develop corrective and preventive actions (CAPA), and implement change controls in a timely and compliant manner.
  • Conduct process equipment periodic reviews, including data integrity and security assessments.
  • Collect, analyze, and present data for operational issues and engineering projects of varying complexity.
  • Lead or support engineering projects within schedule, budget, and quality constraints.
  • Manage commissioning and qualification activities such as FAT, SAT, automation checkouts, IQ, OQ, PQ, and ensure asset, preventive maintenance, and spare parts creation for new process equipment.
  • Participate in system walk-downs, ensure closure of punch list items, and facilitate smooth transition of systems from project to operations.
  • Provide timely support for client inquiries during normal working hours and after-hours, if required.
  • Ensure qualified and experienced personnel are placed on-site for durations based on client needs. Any change in assigned personnel will require client approval.
  • Participate in periodic service level performance reviews based on agreed KPIs with the client.
  • Proactively recommend continuous improvement initiatives, including cost reduction and technical enhancements to optimize equipment performance.
Required Qualifications
  • Degree/Diploma in Mechanical Engineering or a related field.
  • 3-5 years of experience in process equipment maintenance, troubleshooting, and reliability within a biotechnology, pharmaceutical, or GMP-regulated environment.
  • Strong expertise in biotech process equipment and single-use systems.
  • Hands-on knowledge of equipment qualification protocols (FAT, SAT, IQ, OQ, PQ).
  • Understanding of Operational Excellence (Lean, Six Sigma) principles.
  • Strong problem-solving skills and ability to work independently or within a team.
  • Excellent communication skills for effective collaboration with cross-functional teams and stakeholders.
Why join us?
  • Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
  • Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
  • Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
  • Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
  • Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to applyAre you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!Please submit your resume, outlining your qualifications and experience relevant to the role, here.