The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Sr. Process Engineer in Boston, MA.

Role Description

• Drive technology transfers and clinical manufacturing activities such as process performance qualification, aseptic process validation, regulatory submissions, scale-out, process training and technical support.
• Triage operational challenges and deviations with internal stakeholders and Decentralized Manufacturing units (DMUs) to ensure compliance and qualification/batch progress.
• Lead/support operational activities through the stages of technology transfer and continued operations, as well as training and continuous improvement activities.
• Ensure consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform. Write and review electronic batch records, SOPs, protocols & reports.
• Perform data trending and analysis for Key Performance Indicators related to operational performance.
• Support and lead initiatives for equipment, facility and engineering workstreams related to manufacturing at DMUs and interact with external stakeholders and vendors where required to drive improvements.
• Support GMP activities at the decentralized manufacturing sites as part of tech transfers and clinical manufacturing, including equipment qualification, production training, aseptic process validation, process qualification runs, operational readiness.
• Provide 24/7 technical support service for the decentralized manufacturing sites, providing front-line troubleshooting, deviation management, escalation, coordination of subject matter experts to ensure timely release of CAR-T products meeting quality/regulatory requirements.
• Ability to relay technical information and mentor peers. Contribute with technical training both, hands-on as well as documentation.

Skills & Requirements

• Education (add qualification if relevant) & experience:
• BSc/MSc in life sciences, biotechnology, engineering or related discipline
• Experience with cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfer, process validation and/or process development
• Experience of providing hands on training is a plus.
• Experience of management of quality records and documentation review and writing.

General skills:
• Strong interpersonal, verbal and written communication skills
• Ability to be flexible with changing priorities
• Result-driven and can-do mindset, without compromising quality and compliance

Language Skills:
• Good interpersonal skills and written and spoken fluency in English

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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