GMP Facilities Engineer
San Diego, CA 
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Posted 13 days ago
Job Description

Job Summary

The GMP Facility Engineer is responsible for supporting GMP 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, compliant with applicable regulatory requirements, and industry best practices.

He or She will conduct independent research to source new equipment, prepare equipment validation protocols, and execute to completion. Participates in a variety of facility/equipment-based projects for GMP improvement. Must be a capable trainer and trusted resource for lab supervisors and Facility team coworkers. Excellent understanding of lab equipment function, maintenance, and repair. Expected to affect useful change in areas such as safety, quality, production performance, and efficiency, with reductions in equipment downtime.

The GMP Facilities Engineer will engage with multiple stakeholders within GMP and across the campus, with frequent coordination with Quality Assurance to ensure a vigorous and accurate program with high levels of compliance, continuous productivity, and innovation to sustain and advance BioLegend's GMP labs. The GMP Facility Engineer will frequently be assigned to projects and maintenance in non-GMP labs, with primary focus on GMP support.

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 process capabilities, safety, and quality practices within the GMP area.
  • Reduce costs through manufacturing 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.

Project Functions

  • Support improvements in equipment selection, validation, and deployment that reinforce CGMP within GMP departments, and also across non-GMP departments as priorities dictate.
  • Participates in projects to develop, introduce, improve, validate, and support semi-automated/fully automated manufacturing processes for the production of biochemical products.
  • Contribute to project teams to design, develop, and continuously improve equipment, processes, safety, and products.
  • Coordinate vendor maintenance repairs, documentation, and follow-on validation.
  • Compose and execute GMP lab equipment validation plans and reports.
  • Proactively determine ROI and initiate capital requests, and purchase requests for additional equipment, tooling, and fixtures required to advance automation, improve processes, and meet production increases.
  • Participate in projects to introduce new products to the production line and to improve existing tooling and equipment.
  • 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.
  • Operates the contamination control/particle and viable counts sampling, collection, and reporting program as well as other contamination, facilities and infrastructure-related programs for GMP operations

Problem Solving Functions

  • Coordinate activities and resolve equipment issues across GMP departments, other groups, and/or projects as assigned.
  • Respond to and/or resolve trouble calls and production challenges. Develop and implement novel approaches to solving non-routine technical problems.
  • Conduct investigations, demonstrate strong technical and problem-solving skills, and display excellent technical writing skills.
  • Assist with and perform investigations into equipment failures, NCRs, CAPAs, manufacturing issues, and audit findings.
  • Partner with the area supervisors to identify gaps between actual throughput and equipment capacity models and create actionable corrective plans.
  • Work cross-functionally with labs, Supply Chain, Quality Assurance, Operations Engineering, and other internal groups to resolve issues.

Educational/Managerial Functions

  • Support training for manufacturing personnel on new equipment, including creation of training materials and trainer responsibilities.
  • Document and update equipment maintenance 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.
  • Other projects or responsibilities as may be required.

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

  • 3 years of experience in a Facilities environment supporting lab equipment and production
  • 3 years of experience working at a biotechnology company, in support of an ISO 13485-certified company
  • 2 years of hands-on experience with writing SOPs, WI's, validations, and other internal technical documents
  • 1 year in equipment validation (IQ/OQ/PQ), including execution and ability to generate basic protocols.

Preferred Qualifications - Education and Experience

  • 3 years of direct GMP experience in a biotechnology industry setting.
  • 3 years of experience operating or maintaining robotics and automated systems/machinery.
  • 4-year degree in Engineering, Biological sciences, or related discipline.
  • 5 years of relevant experience in facilities support of manufacturing, validation, and scale-up within the life sciences industry.
  • Technical training certification in a facilities-related discipline.
  • CMMS, BMS, and MS Office familiarity with the ability to learn new software programs
  • 3 years of experience operating or maintaining robotics and automated systems/machinery.
  • Experience managing improvement projects in a regulated manufacturing environment.
  • Experience in the product development processes for GMP products
  • 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.

The base salary range for this full-time position is $70,000 -$80,000. 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 ouremployees.Beloware 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 ourpage.

*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.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full or Part Time
Required Education
Bachelor's Degree
Required Experience
3+ years
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