CSV Engineer I

4 weeks ago

india PSC Biotech Full time
Job Description

This is a remote position.

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 to form something truly special. When you decide 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 searching for an entry level CSV Engineer to work REMOTE and support PST hours.

  • Provide Test Script development and execution. 
  • Provide Traceability Matrix Generation 
  • Perform execution of CSV protocols
  • Generate and execute validation documents (System Testing, IQ, OQ, PQ, UAT)
  • 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.
  • Other duties as assigned. 

Requirements
  • 0-6 months of experience developing and executing IQ, OQ, PQ test scripts 
  • CSV experience preferred. 
  • Veeva Vault system experience preferred.
  • Effective written and oral communication skills
  • Excellent time management, interpersonal, and problem-solving skills
  • Strong attention to detail
  • Willingness to travel is preferred. 

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
  • Discounted rate at Anytime Fitness
  • 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.

 

#LI-IT1
Requirements
0-6 months of experience developing and executing IQ, OQ, PQ test scripts CSV experience preferred. Veeva Vault system experience preferred. Effective written and oral communication skills Excellent time management, interpersonal, and problem-solving skills Strong attention to detail Willingness to travel is preferred.

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