Growing company in the Raleigh area is looking for a candidate with your background and experience. This is a family oriented organization that invests in the professional growth of their employees.
Responsibilities:
• Execute equipment start- up, commissioning, calibration, SIO (set in operation), IQ/OQ testing at customer sites
• Generate final qualification reports and review results with customers, edit and update for final signature.
• Plan and coordinate documentation (protocols) preparation with resources and customers to be ready for site execution.
• Review and coordinate work of service technicians for field qualification execution and execute/review completed protocols and reports.
• Prepare and coordinate with project manager to insure readiness of the logistics for IQ/OQ and other testing execution.
• Execute isolator equipment and sensor calibrations, HEPA filter certifications, and air flow analysis/visualization testing.
• Insure proper operation of environmental monitoring equipment (particle counters and viable air samplers)
Qualifications:
• 2-5 years of experience in equipment validation/qualification, preferably pharmaceutical equipment.
• Hands-on skills for equipment and sensor calibration and testing, plus HEPA filter certification
• Understanding and awareness of pharmaceutical documentation practices and cGMP manufacturing regulatory environment.
• Minimum 2-year but strongly preferred four Year BS in Engineering, Engineering Technology or similar degree.
• Previous pharma industry experience preferred (minimum 2-3 years), preferably in aseptic processing.
If you are interested in discussing this role with me -please submit your resume for immediate consideration.
EEO/AA Employer/Vet/Disabled.
The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, the Company is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf
We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
(none specified)