PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech it s about more than just a job it s about your career and your future.
Your Role
We are hiring an experienced Commissioning Owners Representative to provide comprehensive Commissioning Services for Facilities Capital this role you will be responsible for ensuring the successful commissioning of systems and equipment from design through to post-handover. You will oversee and coordinate all commissioning activities to ensure systems are properly tested validated and ready for operational use in line with project specifications and industry standards.
- Lead the commissioning process from the design phase through to system handover ensuring all systems meet commissioning readiness requirements.
- Develop and implement Commissioning Plans and Protocols for each project ensuring alignment with industry best practices and project requirements.
- Perform detailed design reviews ensuring systems are feasible for commissioning and meet regulatory and operational standards.
- Oversee the pre-functional and functional testing of systems ensuring that all testing is completed and documented in compliance with Good Engineering Practices (GEPs).
- Coordinate system performance validation ensuring that systems are tested thoroughly and are ready for operational use.
- Maintain and update the issues log tracking any identified problems and ensuring timely resolution.
- Regularly report progress on commissioning activities to project teams highlighting key milestones and any issues that need attention.
- Collaborate with cross-functional teams to ensure that commissioning activities align with the overall project schedule and objectives.
- Ensure the proper documentation of commissioning activities including testing reports validation protocols and final commissioning reports.
- Support post-handover activities ensuring any warranty issues are addressed and systems continue to meet performance standards.
- Attend required trainings as needed.
- Ensure compliance with industry regulations and requirements always.
- Additional responsibilities as required.
Requirements
- Bachelor s degree in engineering or a related technical discipline.
- 10 years of experience supporting commissioning qualification and validation (CQV) activities in pharmaceutical or life science environments.
- Hands-on experience assisting with the commissioning of facility systems such as HVAC plumbing and clean utility equipment.
- Familiarity with technical documentation including reviewing and contributing to protocols test plans and system specifications.
- Basic understanding of engineering requirements system performance criteria and regulatory standards (e.g. cGMP FDA ISO).
- Experience supporting the execution of commissioning plans and participating in equipment testing and troubleshooting.
- Collaborative team player with exposure to cross-functional coordination including working with vendors contractors and internal stakeholders to meet project timelines.
- At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
Benefits
Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
- Medical Dental and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rates at Anytime and 24-Hour Fitness
- Financial Perks and Discounts
Equal Opportunity Employment Statement:
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employer-sponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
#LI-RW1
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients success and you can be a part of o...
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech it s about more than just a job it s about your career and your future.
Your Role
We are hiring an experienced Commissioning Owners Representative to provide comprehensive Commissioning Services for Facilities Capital this role you will be responsible for ensuring the successful commissioning of systems and equipment from design through to post-handover. You will oversee and coordinate all commissioning activities to ensure systems are properly tested validated and ready for operational use in line with project specifications and industry standards.
- Lead the commissioning process from the design phase through to system handover ensuring all systems meet commissioning readiness requirements.
- Develop and implement Commissioning Plans and Protocols for each project ensuring alignment with industry best practices and project requirements.
- Perform detailed design reviews ensuring systems are feasible for commissioning and meet regulatory and operational standards.
- Oversee the pre-functional and functional testing of systems ensuring that all testing is completed and documented in compliance with Good Engineering Practices (GEPs).
- Coordinate system performance validation ensuring that systems are tested thoroughly and are ready for operational use.
- Maintain and update the issues log tracking any identified problems and ensuring timely resolution.
- Regularly report progress on commissioning activities to project teams highlighting key milestones and any issues that need attention.
- Collaborate with cross-functional teams to ensure that commissioning activities align with the overall project schedule and objectives.
- Ensure the proper documentation of commissioning activities including testing reports validation protocols and final commissioning reports.
- Support post-handover activities ensuring any warranty issues are addressed and systems continue to meet performance standards.
- Attend required trainings as needed.
- Ensure compliance with industry regulations and requirements always.
- Additional responsibilities as required.
Requirements
- Bachelor s degree in engineering or a related technical discipline.
- 10 years of experience supporting commissioning qualification and validation (CQV) activities in pharmaceutical or life science environments.
- Hands-on experience assisting with the commissioning of facility systems such as HVAC plumbing and clean utility equipment.
- Familiarity with technical documentation including reviewing and contributing to protocols test plans and system specifications.
- Basic understanding of engineering requirements system performance criteria and regulatory standards (e.g. cGMP FDA ISO).
- Experience supporting the execution of commissioning plans and participating in equipment testing and troubleshooting.
- Collaborative team player with exposure to cross-functional coordination including working with vendors contractors and internal stakeholders to meet project timelines.
- At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
Benefits
Offering a full suite of benefits PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
- Medical Dental and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rates at Anytime and 24-Hour Fitness
- Financial Perks and Discounts
Equal Opportunity Employment Statement:
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employer-sponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
#LI-RW1
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