Job Description

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PSC Biotech provides life sciences with essential services to ensure that healthcare products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients\xe2\x80\x99 success, and you can be a part of our team\xe2\x80\x99s achievements. Employing a global team of skilled professional 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\xc2\xae 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 a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech\xc2\xae, it\xe2\x80\x99s about more than just a job\xe2\x80\x94it\xe2\x80\x99s about your career and your future.

Your Role

We are hiring a Senior CSV Engineer with at least 7-10 years of experience in computer systems validation. The candidate must have strong experience with test script writing. The Senior CSV Engineer will be responsible for ensuring the compliance and validation of laboratory equipment and instruments within the pharmaceutical domain. The role involves collaborating with cross-functional teams to ensure that validation documentation meets regulatory requirements and quality standards. The specialist will also contribute to the initiation and maintenance of GxP (Good Practice) and Risk Assessments for systems, as well as the authoring, review, and approval of scheduled periodic reviews.

• Provide CSV authoring, review, and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards.

• Initiate/update GxP and Risk Assessments on the system.

• Author, review, and/or approve scheduled periodic reviews.

• Author, initiate, and/or review and approve IT SOPs related to compliance.

• Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements.

• Draft and execute computer system validation documentation such as:

• Validation Project Plan

• Requirement Specification (URS, DS, FS)

• IQ and OQ Test Scripts

• IQ/OQ/PQ Protocols, as necessary

• Traceability Matrix (TMX)

• System Release Memo

• Validation Summary Report

Requirements

• Bachelor\xe2\x80\x99s Degree in Chemical Engineering, Biomedical Engineering, Computer Science, or IT/IS from a 4-year University.

• 6-10 years of CSV experience.

• Must have strong written and verbal communication skills.

• Previous experience in GxP Industries, specifically in Pharmaceuticals and Device industries.

• Previous experience in the IT Industry.

• Computer system validation experience on Pharmaceutical laboratory equipment and instruments (such as HPLC, UV-VIS, and other stand-alone instruments) and Pharmaceutical manufacturing equipment.

• 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.

Benefits

Offering a full suite of benefits, PSC Biotech\xe2\x84\xa2 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.

• PTO, Sick Time, and Paid Holidays

• Education Assistance

• Pet Insurance

• Discounted rate at Anytime Fitness

• Financial Perks and Discounts

\xe2\x80\x8bEqual 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\xe2\x80\x99s, employee\xe2\x80\x99s, or intern\xe2\x80\x99s 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.

PSC Biotech