Join a top-tier global pharma leader in Sturtevant, WI, as a Quality Systems Engineer. This hybrid role (3 days onsite) offers the unique opportunity to bridge the gap between IT and Life Sciences, driving operational excellence by developing, validating, and maintaining critical Quality System applications and data visualization tools.
location: Sturtevant, Wisconsin
job type: Contract
work hours: 9 to 5
education: Bachelors
responsibilities:
- Application Management: Lead the configuration, support, and user administration for key quality and manufacturing business applications.
- System Validation: Author and execute Computer Systems Validation (CSV) documentation in strict compliance with GxP and 21 CFR Part 11 regulations.
- Project Leadership: Serve as the technical expert managing project scopes, budgets, and timelines for major system upgrades and deployments.
- Cross-Functional Collaboration: Partner with engineering teams and end-users to translate business requirements into functional digital designs.
- Regulatory Support: Act as the CSV subject matter expert during formal regulatory audits and inspections.
qualifications:
Required:
- Education: Bachelor's degree in Computer Science, Life Sciences, or a related field.
- Experience: 5+ years of computer software support or CSV experience within a regulated industry.
- Compliance Knowledge: Strong understanding of GAMP 5, 21 CFR Part 11, and Annex 11 validation standards.
- Skills: Proficient in MS Office, excellent technical writing, and strong cross-functional communication skills.
- Experience with application configuration.
- Hands-on experience with eQMS platforms like MasterControl or SmartSolve.
skills: Good Manufacturing Practices (GMP), Equipment Validation
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
