Job DescriptionPSC Biotech providesthelife sciences with essential services to ensure thathealth careproducts are developed, manufactured, anddistributed to thehighest standards, in compliance with allapplicable regulatoryrequirements.
Our goal is toskyrocketour clients' success, and you can be a part of ourteam'sachievements. Employing a global team of skilledprofessionals andexperts that span across strategicallylocated offices in NorthAmerica, Europe, Asia and the MiddleEast, we are proud of theroles we have fulfilled to help ourclients achieve success.
TheExperienceWith operationsspanningthe globe and featuring a multi-cultural team, PSCBiotech ispassionate about bringing the best and brightesttogether in aneffort to form something truly special. Whenyou make the decisionto join our team, you will be offeredthe ability to feel inspiredin your career, explore yourprofessional passions, and workalongside a group of peoplewho will value and nurture your talents.
We are firm believersincoaching and developing the next generation of industryleadersand influencers. As such, you will not only beofferedcompensation and benefits structure that rewards you,but also beprovided with the tools that will help you growand learn.
At PSC Biotech , it'sabout more than just a job-it's about your career and yourfuture.
Your RoleThe 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,manyof our projects and clients are located invarious regionsaround the country. Therefore, wevalue candidates who arewilling and able to travelas needed for project assignmentsand clientengagements. The ability to adapt to differentlocations, cultures, and work environments is essential, as itallows our team members to collaborate effectively withclients and colleagues nationally.
- Must be authorized towork in the US.
- No C2C at thistime.
BenefitsW2 Temp roles include our Medical and Sick Time benefits
EqualOpportunity Employment Statement PSC is committed to a policy of Equal Employment Opportunity with respectto all employees, interns, and applicants for employment.Consistent with this commitment, our policy is to comply with allapplicable federal, state and local laws concerning employmentdiscrimination. Accordingly, the Company prohibits discriminationagainst qualified employees, interns and applicants in all aspectsof 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 activitiesand programs,including wellness, social and recreationalprograms. Employment decisions will be made without regard to anapplicant's, employee's, or intern's actual or perceived: race,color, religion, sex (including pregnancy, gender identity, andsexual orientation), national origin, age (40 or older),disability, genetic information, or any other status protected bylaw.
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