Trinity Consultants - Advent Engineering
IMPORTANT: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.
ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada, and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design, process engineering, and quality system projects.
ADVENT’s services include process engineering, automation engineering, project engineering, facility/system design, start‑up and commissioning, validation, and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
The successful candidate will work with a group of engineers involved in the design, automation, commissioning, and start‑up of various processes, systems, and facilities. A combination of strong technical aptitude, automation engineering skills, and technical writing are the desired skill set.
Responsibilities
Execute IC/OC commissioning protocols for fermenters and the CIP skid
Troubleshoot and resolve all commissioning issues
Generate the commissioning summary reports for all respective protocols
Generate qualification protocols for the fermenters & CIP skids
Troubleshoot and resolve all qualification issues
Generate qualification summary reports for all respective protocols
Assist in or generate the CIP and SIP cycle development protocols
Execute the CIP and SIP cycle development protocols
Resolve all issues encountered
Generate the required subsequent reports
Assist in generating the required PQ protocols
Execute the PQ protocols
Resolve all issues encountered
Qualifications
Requires a bachelor’s or master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical, or Biochemical Engineering). 2‑10 years of experience in a biotech‑pharmaceutical academic or industrial environment.
5+ years of experience in CQV within a regulated biotech or pharmaceutical environment.
Basic knowledge of fermenters and unit operations of fermenters
Basic knowledge of cycle development for CIP and SIP
Basic knowledge of regulatory compliance including cGMP, OSHA, EPA, and FDA regulations
Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, SharePoint, etc., and experience working within shared work environments.
Basic knowledge of Commissioning and Qualification processes
Basic knowledge of using a Kaye Validator
Candidates please note: Kindly ONLY apply if you meet the experience expectations described: Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality, or manufacturing is a MUST. Interested candidates with direct related experience in US or Toronto locations are encouraged to apply. Accepting US Citizens and Green Card Holders.
Seniority level Mid‑Senior level
Employment type
Full‑time
Job function
Engineering and Consulting
Industries
Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
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ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada, and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design, process engineering, and quality system projects.
ADVENT’s services include process engineering, automation engineering, project engineering, facility/system design, start‑up and commissioning, validation, and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
The successful candidate will work with a group of engineers involved in the design, automation, commissioning, and start‑up of various processes, systems, and facilities. A combination of strong technical aptitude, automation engineering skills, and technical writing are the desired skill set.
Responsibilities
Execute IC/OC commissioning protocols for fermenters and the CIP skid
Troubleshoot and resolve all commissioning issues
Generate the commissioning summary reports for all respective protocols
Generate qualification protocols for the fermenters & CIP skids
Troubleshoot and resolve all qualification issues
Generate qualification summary reports for all respective protocols
Assist in or generate the CIP and SIP cycle development protocols
Execute the CIP and SIP cycle development protocols
Resolve all issues encountered
Generate the required subsequent reports
Assist in generating the required PQ protocols
Execute the PQ protocols
Resolve all issues encountered
Qualifications
Requires a bachelor’s or master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical, or Biochemical Engineering). 2‑10 years of experience in a biotech‑pharmaceutical academic or industrial environment.
5+ years of experience in CQV within a regulated biotech or pharmaceutical environment.
Basic knowledge of fermenters and unit operations of fermenters
Basic knowledge of cycle development for CIP and SIP
Basic knowledge of regulatory compliance including cGMP, OSHA, EPA, and FDA regulations
Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, SharePoint, etc., and experience working within shared work environments.
Basic knowledge of Commissioning and Qualification processes
Basic knowledge of using a Kaye Validator
Candidates please note: Kindly ONLY apply if you meet the experience expectations described: Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality, or manufacturing is a MUST. Interested candidates with direct related experience in US or Toronto locations are encouraged to apply. Accepting US Citizens and Green Card Holders.
Seniority level Mid‑Senior level
Employment type
Full‑time
Job function
Engineering and Consulting
Industries
Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
#J-18808-Ljbffr