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 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 motivated and hands-on engineers with direct experience in commissioning qualifying and validating pharmaceutical manufacturing facilities utilities and large-scale process equipment. This role is critical to ensuring the successful startup and compliance of complex systems used in regulated environments. You will be responsible for developing and executing validation protocols troubleshooting equipment and generating comprehensive lifecycle documentation.
- Develop and execute commissioning qualification and validation protocols (IQ/OQ/PQ) for cleanroom environments and large process equipment.
- Write and review technical documentation including specifications (URS FS DS) SOPs risk assessments and final reports.
- Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory expectations.
- Conduct impact gap and risk assessments to identify potential issues and implement mitigation strategies.
- Analyze test data and acceptance criteria to ensure accuracy and compliance.
- Operate and troubleshoot equipment during startup and validation phases to assess performance and recommend modifications.
- Ensure all validation activities meet current industry standards and regulatory requirements (cGMP FDA etc.).
- Additional responsibilities as needed to support project deliverables.
Requirements
- Bachelors degree in Engineering or a related technical field.
- 2 7 years of hands-on experience commissioning qualifying and validating process equipment within the pharmaceutical manufacturing industry.
- Experience qualifying cleanroom facilities.
- Experience in large process equipment in pharmaceutical manufacturing (vessels centrifuges filter presses and CIP skids).
- Experienced writing and generating technical validation documentation including final summary reports IQOQPQ protocols specifications (URS FS DS) operating procedures etc.
- Proven knowledge of regulatory requirements and industry standards (cGMP FDA etc.).
- Strong understanding of risk-based validation approach.
- Excellent analytical problem-solving and communication skills.
- Ability to manage multiple projects and work both independently and collaboratively.
- Ability to work extended hours
- 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
Adhering to the requirements of Californias law on salary transparency the salary bracket for this role is set between $85000 - $100000 annually. The salary offered may be adjusted based on various factors such as the applicants qualifications skills and professional experience.
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-RD1
Required Skills:
Bachelors degree in Engineering or a related technical field. 2 7 years of hands-on experience commissioning qualifying and validating process equipment within the pharmaceutical manufacturing industry. Experience qualifying cleanroom facilities. Experience in large process equipment in pharmaceutical manufacturing (vessels centrifuges filter presses and CIP skids). Experienced writing and generating technical validation documentation including final summary reports IQOQPQ protocols specifications (URS FS DS) operating procedures etc. Proven knowledge of regulatory requirements and industry standards (cGMP FDA etc.). Strong understanding of risk-based validation approach. Excellent analytical problem-solving and communication skills. Ability to manage multiple projects and work both independently and collaboratively. Ability to work extended hours 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.
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 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 motivated and hands-on engineers with direct experience in commissioning qualifying and validating pharmaceutical manufacturing facilities utilities and large-scale process equipment. This role is critical to ensuring the successful startup and compliance of complex systems used in regulated environments. You will be responsible for developing and executing validation protocols troubleshooting equipment and generating comprehensive lifecycle documentation.
- Develop and execute commissioning qualification and validation protocols (IQ/OQ/PQ) for cleanroom environments and large process equipment.
- Write and review technical documentation including specifications (URS FS DS) SOPs risk assessments and final reports.
- Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory expectations.
- Conduct impact gap and risk assessments to identify potential issues and implement mitigation strategies.
- Analyze test data and acceptance criteria to ensure accuracy and compliance.
- Operate and troubleshoot equipment during startup and validation phases to assess performance and recommend modifications.
- Ensure all validation activities meet current industry standards and regulatory requirements (cGMP FDA etc.).
- Additional responsibilities as needed to support project deliverables.
Requirements
- Bachelors degree in Engineering or a related technical field.
- 2 7 years of hands-on experience commissioning qualifying and validating process equipment within the pharmaceutical manufacturing industry.
- Experience qualifying cleanroom facilities.
- Experience in large process equipment in pharmaceutical manufacturing (vessels centrifuges filter presses and CIP skids).
- Experienced writing and generating technical validation documentation including final summary reports IQOQPQ protocols specifications (URS FS DS) operating procedures etc.
- Proven knowledge of regulatory requirements and industry standards (cGMP FDA etc.).
- Strong understanding of risk-based validation approach.
- Excellent analytical problem-solving and communication skills.
- Ability to manage multiple projects and work both independently and collaboratively.
- Ability to work extended hours
- 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
Adhering to the requirements of Californias law on salary transparency the salary bracket for this role is set between $85000 - $100000 annually. The salary offered may be adjusted based on various factors such as the applicants qualifications skills and professional experience.
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-RD1
Required Skills:
Bachelors degree in Engineering or a related technical field. 2 7 years of hands-on experience commissioning qualifying and validating process equipment within the pharmaceutical manufacturing industry. Experience qualifying cleanroom facilities. Experience in large process equipment in pharmaceutical manufacturing (vessels centrifuges filter presses and CIP skids). Experienced writing and generating technical validation documentation including final summary reports IQOQPQ protocols specifications (URS FS DS) operating procedures etc. Proven knowledge of regulatory requirements and industry standards (cGMP FDA etc.). Strong understanding of risk-based validation approach. Excellent analytical problem-solving and communication skills. Ability to manage multiple projects and work both independently and collaboratively. Ability to work extended hours 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.
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Job Location:
Monthly Salary:
$ 85000 - 100000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
