Curia Senior Process Engineer in Hopkinton, Massachusetts
The Impact Is Real.
So are the career advantages.
Help connect ideas to solutions with an employer of choice: Curia.
Contribute to the creation and distribution of treatments that enhance lives. Make medicines more accessible. And help breakthroughs break through faster. At Curia, a global contract research, development, and manufacturing organization, our impact is real. So is your opportunity for a significant, satisfying career. As an employer of choice supporting the top 10 pharmaceutical companies, we offer numerous career advantages. In addition to competitive pay and meaningful benefits, you’ll enjoy the empowerment to be the difference, the chance to work with a diverse team of talented people, a culture that inspires success, and an award-winning workplace. Stop waiting for your future to arrive. Shape it every day with Curia.
Essential Duties and Responsibilities:
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.
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
Lead and ensure 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 expertise and leadership 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
Skills & Qualification:
Bachelor’s Degree or higher in Biochemical Engineering, Molecular Biology Biochemistry, or related discipline
5 or more years (3 or more years with Master’s degree or higher) of experience in bioprocess development with at least 3 years working in the GMP biotech industry
Prior GMP gene therapy and/or biologics manufacturing experience for clinical/commercial stage products is required.
Experience with single-use systems such as bioreactors, purification columns preferred
Solid knowledge of 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
U.S. employees of Curia Global Inc. and its subsidiaries (a “Company”) hired after December 7, 2021 must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law.
The Senior Process Engineer 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.
Work is performed in an office and GMP cleanroom environment. May be exposed to biological and chemical hazards. The employee is required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. Light to moderate lifting and carrying objects with a maximum lift of 30lbs. M ust be able to work while wearing personal protective equipment such as safety glasses, gloves, and coveralls deemed necessary to protect product and to protect employees. Work is to be performed on site.
All interested applicants must apply online. We are 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.
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