What are the responsibilities and job description for the Process Engineer; Manufacturing position at Curia?
Job Description
PROCESS ENGINEER I in Hopkinton, MA
Build your future at Curia, where our work has the power to save lives
Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.
The Process Engineer I position provides a unique opportunity for a person aspiring to join and contribute to a fast-paced team at a rapidly expanding company with a cutting-edge technology platform and ample opportunity to grow with the company. This is a hands-on position with majority of time spent ensuring smooth start-up of new GMP suite and implementing efficient workflows. Process Engineer would conduct cell culture, purification and aseptic fill operations as required. Process Engineer would author and revise documents such as batch records, material specifications, SOPs, deviations/CAPAs, and technical reports. Additionally, this role is a key communication and technical interface between the GMP operations and Quality and Process Sciences. The candidate will have solid knowledge of biologics upstream and downstream processes, cGMP principles, ICH, FDA and EU guidance documents, and quality systems.
We Proudly Offer
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
PROCESS ENGINEER I in Hopkinton, MA
Build your future at Curia, where our work has the power to save lives
Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.
The Process Engineer I position provides a unique opportunity for a person aspiring to join and contribute to a fast-paced team at a rapidly expanding company with a cutting-edge technology platform and ample opportunity to grow with the company. This is a hands-on position with majority of time spent ensuring smooth start-up of new GMP suite and implementing efficient workflows. Process Engineer would conduct cell culture, purification and aseptic fill operations as required. Process Engineer would author and revise documents such as batch records, material specifications, SOPs, deviations/CAPAs, and technical reports. Additionally, this role is a key communication and technical interface between the GMP operations and Quality and Process Sciences. The candidate will have solid knowledge of biologics upstream and downstream processes, cGMP principles, ICH, FDA and EU guidance documents, and quality systems.
We Proudly Offer
- Generous benefit options (eligible first day of employment)
- Paid training, vacation and holidays (vacation accrual begins on first day of employment)
- Career advancement opportunities
- Education reimbursement
- 401K program with matching contributions
- Learning platform
- And more!
- Conduct upstream processes such as cell manipulations in BSC and operation of single use bioreactors
- Conduct downstream processes such as operation of chromatography skid, centrifuge, TFF and isolator manipulations
- Be primary technical point of contact within Manufacturing, supporting gene therapy or biologics process development and production activities.
- Maintain expertise in gene therapy or biologics-related cell culture, purification, analytical strategies, equipment, and processes
- Support efforts for robust, scalable, commercially-viable gene therapy or biologics manufacturing processes are properly developed
- Author development reports and/or appropriate sections of regulatory filings for clients
- Generate SOPs, raw material specifications, and master batch records with Manufacturing and Quality SMEs for GMP processes
- Provide process support in the resolution of complex technical or operational problems
- Provide technical training to manufacturing operators and other employees
- Proactively identify and resolve technical and operational issues
- Author/lead process investigations, deviations, CAPA and change controls
- Support external and internal audits
- Bachelor’s Degree or higher in Biochemical Engineering, Chemical Engineering, Molecular Biology Biochemistry, or related discipline
- 0-1 years of experience in bioprocess development or manufacturing
- Prior GMP gene therapy and/or biologics manufacturing experience for clinical/commercial stage products is desired.
- Experience with single-use systems such as bioreactors, purification columns preferred
- Familiarity with cGMP principles, ICH, FDA and EU guidance documents, and quality systems.
- Training in lean manufacturing, 5S and LDI preferred
- Proficient with timeline development and project tracking
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
