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Senior Process Engineer

2 months ago

San Diego, California, United States Revvity Full time
Job Title
Senior Process Engineer
Location(s)
San Diego - BioLegend

About Us

Revvity is a pioneering developer and provider of comprehensive solutions aimed at assisting scientists, researchers, and clinicians in addressing significant global health challenges. Our dynamic team of over 11,000 professionals worldwide is crucial to our success and enables us to innovate relentlessly in the pursuit of improved human health.

Join us at Revvity

BioLegend, a division of Revvity, Inc., is in search of a Senior Process Engineer to enhance our team. The Senior Process Engineer will play a vital role in optimizing manufacturing processes through a variety of complex tasks including development, implementation, scaling, optimization, and automation. Candidates should possess sufficient experience to perform these responsibilities independently while coordinating closely with stakeholders and adhering to company policies and best practices. This role includes conducting independent research to develop and validate new protocols and serving as a knowledgeable trainer and resource for junior engineers. The Senior Process Engineer will implement improvement methodologies such as Lean, Six Sigma, and Quality Tools, utilizing data analysis and project management to drive enhancements in safety, quality, production performance, and efficiency, while minimizing waste and variability. This position will involve collaboration with multiple departments to ensure a robust and precise program that fosters continuous productivity and innovation in BioLegend's manufacturing processes.

***Consideration will also be given to Manufacturing Process Engineer I/II candidates***

Key Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

General Responsibilities
  • Utilize systematic thinking and technical expertise to independently tackle a wide range of complex issues.
  • Enhance process capabilities and uphold safety and quality standards within the manufacturing sector.
  • Achieve cost reductions through process enhancements or component cost management.
  • Boost efficiency, adaptability, and workplace conditions to improve safety, yield, capacity, and product quality.
  • Champion and support continuous improvement initiatives in manufacturing.
Leadership Responsibilities
  • Direct improvements in processes and methods that reinforce cGMP standards within departments and across the site.
  • Lead projects aimed at developing, introducing, enhancing, validating, and supporting semi-automated or fully automated manufacturing processes for biochemical products.
  • Participate in project teams to design, develop, and continuously enhance safety, product, equipment, fixtures, and processes.
  • Conduct time studies to evaluate line capacity and identify improvement opportunities.
  • Create and maintain production line models to assess capacity and proactively initiate ROI and procurement requests for necessary equipment and tooling.
  • Oversee projects for introducing new products to the production line and improving existing tools and procedures.
  • Review BOMs and facilitate the integration of NPI into manufacturing.
  • Design lab layouts and execute plans to optimize production lines and processes while accommodating new products.
Problem-Solving Responsibilities
  • Coordinate activities and resolve issues across departments and projects.
  • Address recurring processing challenges and develop innovative solutions for complex technical problems.
  • Conduct investigations, demonstrating strong technical and analytical skills along with excellent technical writing abilities.
  • Assist in investigating process failures, NCRs, and manufacturing issues, documenting findings accordingly.
  • Collaborate with Quality Control to address quality concerns from internal and external suppliers.
  • Work with area supervisors to identify discrepancies between actual throughput and capacity models, creating actionable corrective plans.
  • Engage cross-functionally with Process and Product Development, Supply Chain, Quality Control, and Quality Assurance to resolve issues.
  • Review ECOs to ensure the accuracy of BOMs and their integration into manufacturing processes.
Educational and Managerial Responsibilities
  • Support training initiatives for manufacturing personnel on new processes and improvements.
  • Document and update work instructions and SOPs to enhance production lines.
  • Effectively communicate information through updates, reports, and summaries.
  • Monitor and report key performance indicators, including safety, output, yields, quality, lead times, back orders, and delays, striving to meet goals.
Minimum Qualifications - Education and Experience
  • BS Degree or higher in relevant engineering disciplines (chemical engineering, biochemical engineering, bioengineering, biomedical engineering, or related scientific field).
  • A minimum of 6 years of relevant experience in manufacturing, process development, and validation within the biotech or life sciences sector.
  • Direct experience with continuous improvement methodologies (Lean, Six Sigma) including DMAIC projects, visual management, value stream mapping, 5S, and Kaizen.
  • Experience managing improvement projects in a regulated manufacturing environment.
  • Strong statistical and analytical skills for root cause problem-solving.
  • Familiarity with biotech-related manufacturing processes, including antibody/protein separation and chromatography.
  • Proven ability to lead cross-functional teams to achieve desired outcomes.
  • Demonstrated capacity to independently manage multiple projects and priorities efficiently.
  • Proficient in Microsoft Suite (Excel, PowerPoint, Word, Visio, Project).
  • Able to present information clearly and concisely through various formats (emails, reports, presentations).
Preferred Qualifications - Education and Experience
  • Experience with Process Validation (IQ/OQ/PQ) and capable of generating protocols and test reports.
  • Experience in setting up BOMs and parts management to support manufacturing lines.
  • Knowledge of FDA regulations (21CFR 820), ISO13485, and ISO standards related to medical device manufacturing.
Compensation and Benefits
The base salary range for this full-time position is $100,000-$130,000/year. This range reflects the minimum and maximum target for a new hire in this position. The actual base pay offered will consider internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training.

Revvity is dedicated to fostering a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. Revvity is committed to a culturally diverse workforce.