Sr. Process EngineerBillerica, MAROLE SUMMARY:We are looking for an experienced and motivated candidate to join our Process Development team. In this critical role, this individual will drive the development and deployment of our IVD reagent supply and manufacturing processes, from the lab bench through to production scale. You will design and execute experiments and drive innovations to continuously advance process characterization and scale-up methodology in an FDA-regulated environment. You will identify technical requirements in our products, define appropriate methods, and work with internal and external stakeholders to enable a sustainable reagent operations process.
WHAT YOU'LL DO:- Develop reagent processes and collaborate with Research, Technology and Reagent R&D on IVD and RUO product development.
- Write documentation for IVD and RUO products and processes.
- Deploy analytical test systems in collaboration with Research, Technology and Reagent R&D, Technical Operations and Quality to characterize and qualify reagent components.
- Implement reagent product manufacturing processes, including formulation, filling/finishing, and packaging processes for both IVD and RUO products.
- Continuously improve the reagent manufacturing including supplier technical support, process development and implementation.
- Facilitate root cause analysis and ideation of the improvement opportunities from the metric discussions.
BASIC QUALIFICATIONS:- BS in molecular biology, biochemistry, chemistry, engineering, or a related discipline with 6+ years of experience in product and process development; MS in a related discipline with 5+ years of experience; or PhD in a related discipline with 4+ years of experience.
PREFERRED QUALIFICATIONS:- Experience in biomolecule diagnostics is ideal.
- Small- and large-scale project or process experience, including manufacturing operations experience.
- Experience collaborating cross-functionally with Research, Technology, Reagent R&D, Technical Operations, Quality, and external stakeholders.
- Experience supporting continuous improvement, supplier technical support, root cause analysis, and process implementation activities.
- Demonstrated technical expertise in process and product development in a regulated environment.
- Experience developing, characterizing, qualifying, and implementing reagent product manufacturing processes.
EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:- Workplace location: Billerica, MA; onsite, hybrid, or remote arrangement to be confirmed by the hiring manager.
- Travel: percentage to be confirmed by the hiring manager.
- Physical requirements, including any lifting requirements, to be confirmed by the hiring manager if applicable.
- Self-starter who is flexible in changing direction and methods and thrives in a fast-paced environment.
- Strong technical judgment, documentation discipline, cross-functional collaboration, and problem-solving skills.
Pay Range: $105,000 - $130,000 per year
