CSV Engineer

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 CSV Engineer to support MES for Electronic Batch Records.

• Participate in the development of MES system life cycle strategy and business / technical processes for change management.
• MES system configuration, programming, troubleshooting, and testing.
• Accurately and efficiently complete project deliverables : URS, FRS, OQ, PQ, VMP, TM, ECOs, etc.
• Perform execution of CSV protocols.
• Generate and execute validation documents (System Testing, IQ, OQ, PQ, UAT).
• Write Software Configuration Documentation, including validation plan, test cases, and validation summary.
• Provide a range of support in a variety of CSV tasks.
• Participate / support the planning, development, and implementation of computer systems validation documentation.
• Initiate and oversee system CSV associated change control requests and associated validation documentation.
• Author, Review and or approve scheduled periodic reviews.
• Participate in computer validation project activities and create computer system planning documents and testing protocols.
• Review test results and identify areas of improvement to implement changes.
• Review and modify Standard Operating Procedures (SOPs).
• Review and analyze validation data compiling reports when required.
• Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and / or justifications to system requirements.
• Additional requirements as assigned.

Requirements

• 3-5 years of Computer Systems Engineering experience.
• Technical background in IT / Engineering.
• Experience working in the Pharmaceutical industry, preferably within eye care.
• Experience in cGMP manufacturing environment.
• Must have experience working with Siemens MES.
• Ability to read and interpret dimensional specifications and drawings.
• Experienced with strong knowledge in CSV deliverable such as URS, FRS, OQ, PQ, VMP, TM, ECOs, etc.
• Strong learning initiative.
• Strong interpersonal skills and excellent communication skills.
• Team player with the ability to work with internal and external suppliers.
• 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 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

3-5 years of Computer Systems Engineering experience. Technical background in IT / Engineering. Experience working in the Pharmaceutical industry, preferably within eye care.

Experience in cGMP manufacturing environment. Must have experience working with Siemens MES. Ability to read and interpret dimensional specifications and drawings.

Experienced with strong knowledge in CSV deliverable such as URS, FRS, OQ, PQ, VMP, TM, ECOs, etc. Strong learning initiative.

Strong interpersonal skills and excellent communication skills. Team player with the ability to work with internal and external suppliers.

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.