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 junior-mid level Validation Engineers. This position plays a critical role in ensuring successful execution of commissioning qualification and validation of laboratory equipment facility systems and utilities offering an excellent opportunity for professional growth and development in the pharmaceutical industry.
- Support the writing development and execution of commissioning qualification and validation protocols for a range of laboratory equipment facility systems and utilities.
- Draft review and generate all required validation documentation including protocols reports master plans risk assessments procedures reports and so on.
- Execute hands-on testing and analysis during qualification and validation tasks.
- Participate in risk assessments and impact assessment; support troubleshooting and risk resolution.
- Document test results deviations and investigations in compliance with company procedures and regulatory standards.
- Perform temperature mapping studies for controlled environments lab spaces warehouses CTUs etc. and assist with supporting testing reporting and improvement initiatives.
- Collaborate with cross functional teams to support all project timelines and deliverables.
- Contribute to the continuous improvement of validation processes and procedures.
- Ensure compliance with industry regulations and requirements.
- Additional responsibilities as required.
Requirements
- Bachelors degree in related engineering discipline.
- 2 years of experience in a validation role having executed CQV protocols for a range of laboratory equipment facilities and utilities.
- Experienced in temperature mapping procedures and activities.
- Experienced and proficient with paperless validation systems (ValGenesis KNEAT etc.)
- Experience with controlled systems.
- Strong understanding of regulatory requirements including cGMP FDA etc.
- Strong analytical skills with the ability to problem-solve and troubleshoot effectively.
- Excellent communication and interpersonal skills with the ability to work collaboratively in a team environment.
- Detail-oriented mindset with a commitment to maintaining high-quality standards.
- 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
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24-Hour Fitness and more).
- 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-TP1
Required Skills:
Minimum of 5 years of experience in the manufacturing setting with 3 years of experience in packaging preferably in the pharmaceutical/life science industry. Strong knowledge of packaging equipment and technologies including filling machines labeling systems blister packaging machines and serialization solutions. Experienced in Visual Inspection Systems. Excellent problem-solving skills with the ability to troubleshoot technical issues and implement effective solutions. Detail-oriented with a commitment to maintaining high standards of quality and compliance. Excellent communication and interpersonal skills. Ability to work independently and collaboratively in a fast-paced environment. 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. 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
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 ...
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 junior-mid level Validation Engineers. This position plays a critical role in ensuring successful execution of commissioning qualification and validation of laboratory equipment facility systems and utilities offering an excellent opportunity for professional growth and development in the pharmaceutical industry.
- Support the writing development and execution of commissioning qualification and validation protocols for a range of laboratory equipment facility systems and utilities.
- Draft review and generate all required validation documentation including protocols reports master plans risk assessments procedures reports and so on.
- Execute hands-on testing and analysis during qualification and validation tasks.
- Participate in risk assessments and impact assessment; support troubleshooting and risk resolution.
- Document test results deviations and investigations in compliance with company procedures and regulatory standards.
- Perform temperature mapping studies for controlled environments lab spaces warehouses CTUs etc. and assist with supporting testing reporting and improvement initiatives.
- Collaborate with cross functional teams to support all project timelines and deliverables.
- Contribute to the continuous improvement of validation processes and procedures.
- Ensure compliance with industry regulations and requirements.
- Additional responsibilities as required.
Requirements
- Bachelors degree in related engineering discipline.
- 2 years of experience in a validation role having executed CQV protocols for a range of laboratory equipment facilities and utilities.
- Experienced in temperature mapping procedures and activities.
- Experienced and proficient with paperless validation systems (ValGenesis KNEAT etc.)
- Experience with controlled systems.
- Strong understanding of regulatory requirements including cGMP FDA etc.
- Strong analytical skills with the ability to problem-solve and troubleshoot effectively.
- Excellent communication and interpersonal skills with the ability to work collaboratively in a team environment.
- Detail-oriented mindset with a commitment to maintaining high-quality standards.
- 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
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24-Hour Fitness and more).
- 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-TP1
Required Skills:
Minimum of 5 years of experience in the manufacturing setting with 3 years of experience in packaging preferably in the pharmaceutical/life science industry. Strong knowledge of packaging equipment and technologies including filling machines labeling systems blister packaging machines and serialization solutions. Experienced in Visual Inspection Systems. Excellent problem-solving skills with the ability to troubleshoot technical issues and implement effective solutions. Detail-oriented with a commitment to maintaining high standards of quality and compliance. Excellent communication and interpersonal skills. Ability to work independently and collaboratively in a fast-paced environment. 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. 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
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Posted on:
30+ days ago
Vacancies:
1 Vacancy
