We have an open Quality Engineer (working within Technical Operations) contract-to-hire opportunity that would be a great foot in the door at a growing biotech developing gene therapies for pediatric CNS disorders. This role is onsite in Morrisville, NC Monday through Friday, and is for local, W2 candidates only.
This opportunity is specifically seeking a Quality Engineer who understands how to transition a drug process from the lab to the manufacturing floor (Process Validation). Prior experience in Quality Validation within Cell & Gene Therapy would be perfect!
location: Morrisville, North Carolina
job type: Temporary
salary: $60 - 75 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Equipment and software Qualification (IQ/OQ/PQ) - process and analytical
- Process Validation & Tech Transfer support and review
- Support of PPQ activities
- Review of Facility and Engineering documents, including work orders, asset management, etc.
- QA representative on deviations and investigations for any facility issues.
qualifications:
Required:
- Experience: 5+ years of experience in Quality Engineering and Quality Validation within Biotech industry.
- Education: B.S. in Engineering, Life Sciences, or a related technical discipline.
- Technical Knowledge: Comprehensive understanding of cGMP, GAMP 5, and the validation lifecycle. Experience in Gene Therapy or sterile manufacturing environments is a significant plus.
skills: Corrective and Preventive Actions (CAPA), Quality Management Systems (QMS)
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.
