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 teams 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 make the decision 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 its about more than just a jobits about your career and your future.
Your Role
We are hiring an Owners Representative CQV to join our team! In this role you will serve as the clients technical representative overseeing and directing all commissioning qualification and validation (CQV) activities for large-scale capital projects. This position is highly technical in nature and demands advanced subject-matter expertise in CQV systems sterile manufacturing processes and operations within regulated environments.
- Act as the Owners Representative to lead coordinate and manage the full CQV program throughout the project lifecycle.
- Oversee and direct third-party validation engineers ensuring alignment with project goals technical standards and regulatory expectations.
- Develop maintain and drive the CQV schedule deliverables and resource plans for complex capital projects.
- Provide technical direction and oversight for commissioning qualification and validation of sterile injectable equipment utilities and facility systems.
- Ensure all CQV activities strictly adhere to GMP FDA and global regulatory guidelines.
- Identify assess and mitigate technical and project risks to maintain project continuity and compliance.
- Work closely with engineering quality operations and regulatory teams to ensure technical alignment across the project.
- Manage contractors and vendors responsible for equipment installation testing qualification and documentation.
- Drive the implementation of CQV best practices risk-based approaches and industry standards within sterile or combination product environments.
Requirements
- Bachelors degree in Engineering or a related scientific discipline.
- Minimum 10 years of hands-on validation experience in GMP environments including equipment utilities and process validation.
- Minimum 5 years of project management experience leading large-scale CQV capital projects.
- Demonstrated experience serving as an Owners Representative or leading multi-disciplinary CQV programs.
- Strong technical background in sterile injectable or combination product manufacturing.
- Expertise in industry regulations validation standards and risk-based CQV methodologies.
- Proven ability to manage project schedules budgets and cross-functional teams.
- Exceptional analytical problem-solving and technical communication skills.
- Experience with ATEC systems preferred.
- Willingness to travel as required for project execution and client engagement.
- Must be authorized to work in the US.
- No C2C at this time.
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 rate at Anytime 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 applicants employees or interns 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
Required Skills:
Bachelors degree in Engineering or a related scientific discipline. Minimum 10 years of hands-on validation experience in GMP environments including equipment utilities and process validation. Minimum 5 years of project management experience leading large-scale CQV capital projects. Demonstrated experience serving as an Owners Representative or leading multi-disciplinary CQV programs. Strong technical background in sterile injectable or combination product manufacturing. Expertise in industry regulations validation standards and risk-based CQV methodologies. Proven ability to manage project schedules budgets and cross-functional teams. Exceptional analytical problem-solving and technical communication skills. Experience with ATEC systems preferred. Willingness to travel as required for project execution and client engagement. Must be authorized to work in the US. No C2C at this time.
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 t...
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 teams 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 make the decision 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 its about more than just a jobits about your career and your future.
Your Role
We are hiring an Owners Representative CQV to join our team! In this role you will serve as the clients technical representative overseeing and directing all commissioning qualification and validation (CQV) activities for large-scale capital projects. This position is highly technical in nature and demands advanced subject-matter expertise in CQV systems sterile manufacturing processes and operations within regulated environments.
- Act as the Owners Representative to lead coordinate and manage the full CQV program throughout the project lifecycle.
- Oversee and direct third-party validation engineers ensuring alignment with project goals technical standards and regulatory expectations.
- Develop maintain and drive the CQV schedule deliverables and resource plans for complex capital projects.
- Provide technical direction and oversight for commissioning qualification and validation of sterile injectable equipment utilities and facility systems.
- Ensure all CQV activities strictly adhere to GMP FDA and global regulatory guidelines.
- Identify assess and mitigate technical and project risks to maintain project continuity and compliance.
- Work closely with engineering quality operations and regulatory teams to ensure technical alignment across the project.
- Manage contractors and vendors responsible for equipment installation testing qualification and documentation.
- Drive the implementation of CQV best practices risk-based approaches and industry standards within sterile or combination product environments.
Requirements
- Bachelors degree in Engineering or a related scientific discipline.
- Minimum 10 years of hands-on validation experience in GMP environments including equipment utilities and process validation.
- Minimum 5 years of project management experience leading large-scale CQV capital projects.
- Demonstrated experience serving as an Owners Representative or leading multi-disciplinary CQV programs.
- Strong technical background in sterile injectable or combination product manufacturing.
- Expertise in industry regulations validation standards and risk-based CQV methodologies.
- Proven ability to manage project schedules budgets and cross-functional teams.
- Exceptional analytical problem-solving and technical communication skills.
- Experience with ATEC systems preferred.
- Willingness to travel as required for project execution and client engagement.
- Must be authorized to work in the US.
- No C2C at this time.
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 rate at Anytime 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 applicants employees or interns 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
Required Skills:
Bachelors degree in Engineering or a related scientific discipline. Minimum 10 years of hands-on validation experience in GMP environments including equipment utilities and process validation. Minimum 5 years of project management experience leading large-scale CQV capital projects. Demonstrated experience serving as an Owners Representative or leading multi-disciplinary CQV programs. Strong technical background in sterile injectable or combination product manufacturing. Expertise in industry regulations validation standards and risk-based CQV methodologies. Proven ability to manage project schedules budgets and cross-functional teams. Exceptional analytical problem-solving and technical communication skills. Experience with ATEC systems preferred. Willingness to travel as required for project execution and client engagement. Must be authorized to work in the US. No C2C at this time.
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