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
The Validation Engineer is responsible for supporting the qualification of computerized systems within a regulated life sciences environment. This role will support computerized system lifecycle activities to help ensure systems are appropriately qualified, documented, and maintained in accordance with applicable quality and regulatory requirements.
This is a 6-month W2 temp contract opportunity based in Columbia, MO, with potential for extension. Applicants must be legally authorized to work in the United States. Employer-sponsored work authorization is not available for this position, and Corp-to-Corp (C2C) arrangements will not be considered.
- Support the qualification and validation of computerized systems.
- Develop, review, and execute computer system validation and qualification documentation.
- Support validation activities throughout the computerized system lifecycle.
- Review system requirements and associated documentation for completeness and compliance with established procedures.
- Develop and execute validation protocols and document results in accordance with approved procedures.
- Identify, document, and support the resolution of discrepancies or deviations encountered during qualification and validation activities.
- Collaborate with cross-functional stakeholders, including Quality, Engineering, IT, and system owners, to coordinate validation activities.
- Support change control and assessment activities associated with validated computerized systems.
- Maintain accurate and complete validation documentation in accordance with applicable quality requirements.
- Support inspection and audit readiness by ensuring computerized system validation records are complete and traceable.
- Ensure validation activities are performed in alignment with applicable GMP requirements and site procedures.
Requirements
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical discipline, or equivalent relevant experience.
- 5+ years of experience with computerized system validation (CSV) and/or computerized system qualification in a regulated environment.
- Working knowledge of validation lifecycle principles and documentation.
- Understanding of GMP-regulated systems and applicable quality requirements.
- Experience developing, reviewing, and/or executing validation or qualification documentation.
- Ability to identify and document discrepancies and support resolution of validation issues.
- Strong technical writing, documentation, and organizational skills.
- Effective communication skills with the ability to collaborate across Quality, Engineering, IT, and other functional groups.
- Ability to manage multiple validation activities and priorities while maintaining a high level of attention to detail.
- 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.
- Must be authorized to
work in the US.
- No C2C at this
time.
Benefits
W2 Temp roles include our Medical and Sick Time benefits
Equal
Opportunity Employment Statement
PSC 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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