The Manufacturing Process Engineer III is responsible for supporting manufacturing processes through diverse and challenging efforts in development, implementation, scaling-up, optimization, and automation. Related experience must be sufficient that these tasks are accomplished independently, self-managed in close coordination with stakeholders, and completed in accordance with Company policy and best practices. Conducts independent research to prepare and validate new protocols. Is a capable trainer and trusted resource for less experienced engineers. Establishes improvement methodologies (Lean, Six Sigma, SPC, TPS, Quality Tools, etc.), data analysis, and project management to affect useful change in areas such as safety, quality, production performance, efficiency, with reductions of waste, variability, and process time. The Process Engineer III will engage with multiple departments across the organization to ensure a vigorous and accurate program with high levels of continuous productivity and innovation to sustain and advance BioLegend's manufacturing processes.

Essential Functions

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

Non-specific Functions

• Apply systematic thinking, processes, and technical knowledge to independently address a broad range of non-routine to moderately complex problems.
• Improve the process capabilities, and safety and quality practices within the manufacturing area.
• Reduce costs through manufacturing process improvement or component costs.
• Improve efficiency, flexibility, and work environment to improve safety, yield, capacity, and product quality.
• Support and drive manufacturing continuous improvement initiatives.

Leading Functions

• Lead improvements in processes and methods that reinforce cGMP within a department and/or across the site.
• Lead projects to develop, introduce, improve, validate, and support semi-automated/fully automated manufacturing processes for production of biochemical products.
• Lead and/or participate on project teams to design, develop, and continuously improve safety, product, equipment, fixtures, and/or processes.
• Perform time studies, when needed, to assess line capacity and to identify areas to improve.
• Create and maintain modeling of production lines and manufacturing processes to determine capacity and proactively initiate ROI and purchase requests for additional equipment, tooling, and fixtures that will be needed for volume increases.
• Lead projects to introduce new products to the production line and to improve existing tooling, fixtures, and procedures.
• Review of BOM's and implementation of NPI into manufacturing.
• Create lab layouts and execute plans to expand the production lines and manufacturing processes, and to add new products in a manner that optimizes floor space.

Problem Solving Functions

• Coordinates activities and resolves issue across the department, other groups, and/or projects.
• Respond to and/or resolve recurring processing issues. Develop and implement novel approaches to solving non-routine technical problems.
• Conduct investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills.
• Assist with and perform investigations into process failures, NCRs, manufacturing issues, and document findings accordingly.
• Work with Quality Control to resolve quality issues from internal and external (raw material or OEM) supplier/vendors.
• Work with the area supervisors to identify gaps between actual throughput and capacity models and create actionable corrective plans.
• Work cross functionally with Process and Product Development, Supply Chain, Quality Control and Quality Assurance and other internal groups to resolve issues.
• Review ECO's to ensure correctness of the BOM's and how they are integrated into our manufacturing process.

Educational/Managerial Functions

• Support training for manufacturing personnel on new processes and process improvements.
• Document and update work instructions and SOPs, as needed to maintain and improve the production line.
• Communicate information effectively through updates, reports, and summaries.
• Track and report key performance indicators including safety, output, yields, quality, lead times, back orders, and delays, improving them to meet goals.

iACT Competencies

• innovate - Be better, keep improving, be more efficient, creative, and be in the forefront of development
• Aspire - Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
• Collaborate - Foster teamwork, common goals, selflessness, communication and mutual support
• Transform - Adapt, learn, re-invent and change for future development and growth

Minimum Qualifications - Education and Experience

• BS Degree or higher in applicable engineering disciplines (chemical engineering, biochemical engineering, bioengineering, biomedical engineering or other relevant scientific field).
• Minimum of 6 years of relevant working knowledge in manufacturing, process development and characterization, process design and scale-up, improvement and validation in the biotech or life sciences industry.
• Direct experience with continuous improvement (Lean, Six Sigma) methodologies such as DMAIC projects, visual management, value stream mapping, 5S, Kaizen etc.
• Experience in managing improvement projects in a regulated manufacturing environment.
• Strong statistical / analytical skills- driving root cause problem solving.
• Previous working knowledge of biotech-related manufacturing processes - antibody/protein separation and chromatography, conjugation.
• Demonstrated ability to facilitate and lead cross-functional teams to reach a desired outcome.
• Demonstrated ability to independently manage multiple projects and priorities by organizing work efficiently.
• Knowledge of Microsoft Suite (Excel, PowerPoint, Word, Visio, Project).
• Able to present information in a clear, logical, and concise manner (emails, reports, presentations).

Preferred Qualifications - Education and Experience

• Experience with Process Validation (IQ/OQ/PQ) and able to generate protocols and test reports.
• Experience setting up BOM's and parts management in support of a manufacturing line.
• Knowledge and understanding of FDA regulations (21CFR 820), ISO13485, and ISO standards related to medical device manufacturing.

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 base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.

Work Environment & Physical Demands

Office

While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.

Lab

While performing the duties of this job, the employee regularly works in a laboratory environment with occasional data entry on a computer. Occasional exposure to a warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.

What do we offer?

We provide competitive and comprehensive benefits to our employees.Below are some highlights of our benefits:

• Medical, Dental, and Vision Insurance Options
• Life and Disability Insurance
• Paid Time-Off
• Parental Benefits
• 401k with Company Match
• Employee Stock Purchase Plan

Learn more about Revvity's benefits by visiting our page.

*For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.