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 a dedicated CQV Project Manager. This role delivers comprehensive support to the organization throughout every stage of the CQV lifecycle. You will offer expert guidance in project planning strategic development and execution employing a risk-based methodology to ensure adherence to regulatory standards and the highest levels of product safety.
- Oversee commissioning qualification and validation (CQV) efforts for sterile injectable manufacturing equipment and pharmaceutical site utilities.
- Develop and manage detailed project plans timelines and resource allocation to ensure successful delivery of CQV milestones.
- Collaborate with cross-functional teams including engineering quality assurance operations and regulatory to align CQV activities with project objectives.
- Ensure all CQV activities comply with GMP FDA and other regulatory requirements; maintain accurate documentation and validation protocols.
- Identify potential risks in CQV processes and implement mitigation strategies to maintain project integrity and timelines.
- Manage external vendors and contractors involved in equipment installation qualification and validation.
- Drive process optimization and best practices for CQV methodologies within sterile injectable manufacturing environments.
- Monitor project budgets prepare progress reports and communicate status updates to senior leadership and stakeholders.
Requirements
- Bachelors degree in related engineering discipline.
- 5 years of experience managing end-to-end CQV activities for capital projects including URS development FAT/SAT execution and validation documentation for GMP-compliant sterile injectable manufacturing equipment and pharmaceutical site utilities.
- Experienced managing full CQV lifecycle projects. Highly skilled in project planning and scheduling budget management risk mitigation stakeholder communication and vendor/contractor coordination.
- Well-versed in CQV risk based approach.
- Expertise in industry regulations requirements and guidelines.
- Proven success in project planning initiation execution and closure.
- Strong attention to detail and commitment to quality and compliance.
- Strong problem solving and analytical skills.
- Familiarity with ATEC systems preferred.
- Travel is required. 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.
- 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:
Enrolled in related technical degree programs i.e. Computer Science Networking System Administration etc. Familiar with networking fundamentals (TCP/IP VLANs Cisco switches/firewalls). Basic understanding of virtualization concepts (VMware preferred). Demonstrated knowledge of Windows Server administration (Linux is a plus). Must be local to York PA. Must be able to intern minimum of 15-20 hours per week during academic semester. Strong problem-solving skills and attention to detail. Strong drive and willingness to learn in a regulated environment. Detail-oriented with a commitment to accuracy and quality. Enthusiasm for learning and growth.
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 a dedicated CQV Project Manager. This role delivers comprehensive support to the organization throughout every stage of the CQV lifecycle. You will offer expert guidance in project planning strategic development and execution employing a risk-based methodology to ensure adherence to regulatory standards and the highest levels of product safety.
- Oversee commissioning qualification and validation (CQV) efforts for sterile injectable manufacturing equipment and pharmaceutical site utilities.
- Develop and manage detailed project plans timelines and resource allocation to ensure successful delivery of CQV milestones.
- Collaborate with cross-functional teams including engineering quality assurance operations and regulatory to align CQV activities with project objectives.
- Ensure all CQV activities comply with GMP FDA and other regulatory requirements; maintain accurate documentation and validation protocols.
- Identify potential risks in CQV processes and implement mitigation strategies to maintain project integrity and timelines.
- Manage external vendors and contractors involved in equipment installation qualification and validation.
- Drive process optimization and best practices for CQV methodologies within sterile injectable manufacturing environments.
- Monitor project budgets prepare progress reports and communicate status updates to senior leadership and stakeholders.
Requirements
- Bachelors degree in related engineering discipline.
- 5 years of experience managing end-to-end CQV activities for capital projects including URS development FAT/SAT execution and validation documentation for GMP-compliant sterile injectable manufacturing equipment and pharmaceutical site utilities.
- Experienced managing full CQV lifecycle projects. Highly skilled in project planning and scheduling budget management risk mitigation stakeholder communication and vendor/contractor coordination.
- Well-versed in CQV risk based approach.
- Expertise in industry regulations requirements and guidelines.
- Proven success in project planning initiation execution and closure.
- Strong attention to detail and commitment to quality and compliance.
- Strong problem solving and analytical skills.
- Familiarity with ATEC systems preferred.
- Travel is required. 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.
- 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:
Enrolled in related technical degree programs i.e. Computer Science Networking System Administration etc. Familiar with networking fundamentals (TCP/IP VLANs Cisco switches/firewalls). Basic understanding of virtualization concepts (VMware preferred). Demonstrated knowledge of Windows Server administration (Linux is a plus). Must be local to York PA. Must be able to intern minimum of 15-20 hours per week during academic semester. Strong problem-solving skills and attention to detail. Strong drive and willingness to learn in a regulated environment. Detail-oriented with a commitment to accuracy and quality. Enthusiasm for learning and growth.
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