Job Description

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 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®, it’s about more than just a job it’s about your career and your future.

Your Role

We are hiring a Cleaning Validation Specialist to support the documentation writing for a new cleaning validation protocol.

This is a contract, hybrid position.

• Develop and write cleaning validation protocols and reports.
• Serve as subject matter expert of cleaning validation processes and activities.
• Ensure protocols are in compliance with industry standards, regulatory guidelines, and internal company policies.
• Prepare comprehensive and well-documented final reports for cleaning validation studies.
• Maintain accurate and up-to-date records of all cleaning validation activities.
• Collaborate with cross-functional teams to align on cleaning validation studies / documentation.
• Provide effective communication with stakeholders and customers.
• Additional responsibilities as required.

Requirements

• Bachelors Degree in Engineering or related.
• 10 years of cleaning validation experience in the pharmaceutical industry.
• Subject Matter Expertise in cleaning validation activities, processes, regulations, and standards.
• Advanced experience in generating cleaning validation protocols and reports.
• Excellent technical writing skills.
• Excellent communication and interpersonal skills with the ability to work closely with stakeholders and customers.
• Strong analytical skills, with in-depth data analysis knowledge. Detail-oriented.
• Strong understanding of regulatory requirements related to cleaning validation.
• Ability to work independently and collaboratively in a team 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 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.

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Requirements

Bachelor's Degree in Engineering or related. 10 years of cleaning validation experience in the pharmaceutical industry. Subject Matter Expertise in cleaning validation activities, processes, regulations, and standards.

Advanced experience in generating cleaning validation protocols and reports. Excellent technical writing skills. Excellent communication and interpersonal skills with the ability to work closely with stakeholders and customers.

Strong analytical skills, with in-depth data analysis knowledge. Detail-oriented. Strong understanding of regulatory requirements related to cleaning validation.

Ability to work independently and collaboratively in a team 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 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-TW1

Last updated : 2024-03-28