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Engineer II, Laboratory Operations Supervisor

Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 6, 2021

Job Description:

Job Responsibilities

General

  • Establish or support a robust testing forecast & schedule and resource plan for the lab.

  • Conduct ongoing Regulatory Compliance & Safety Assurance activities. Activities include but not limited to maintaining cGDP/GLP compliance for documents, data, equipment, samples, chemicals, materials, and training status on laboratory and safety procedures to ensure Audit-readiness

  • Participate in internal audit and/or Health Authority inspection including planning, presenting and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions if required.

  • Ensure laboratory operations are performed in accordance with applicable Pharma Quality System requirements and local procedures relevant to medical devices and combination products

  • Collaborate across functions (e.g. device teams, quality, IT, and suppliers) in developing practical and thorough solutions to problems, and execute/ lead testing activities: method validation, equipment qualification, and method transfer.

  • Drive innovations and challenges conventional assumptions to develop and implement new technologies/processes which enhance Design Verification Laboratory performance

  • Work with limited direction. Provide guidance and coordinate work activities with other personnel.

  • May directly manage at least one contract worker.

  • Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices.

  • Create, own, and/or review discrepant events, lab investigations, change records, and risk management documents for PTDU-D and Devices Teams, as needed.

  • Support the laboratory lead in preparing communications for internal review committees, talent acquisition, and resourcing.

Technical

  • Develop, author and/or review Testing Protocols/Plans for Design Verification (DV), Test Method Validation (TMV), and Equipment Qualification (EQ) using specialized knowledge of User/Design/System Requirements, Test Methods, and analytical instruments.

  • Lead and/or execute routine and non-routine mechanical and analytical testing to support the development, verification, commercialization and marketing of various device designs.

  • Develop, author, revise, and/or review Test Methods, Operating Procedures, Work Instructions and templates under Technical Change Management system.

  • Develop, design and rapid prototyping of test fixtures & surrogate samples, as needed.

  • Support equipment/accessories purchasing activities, maintain equipment calibration/qualification status and inventory lists, troubleshoot equipment failures, conduct periodic reviews, support vendor on-site services, and ensure data integrity.

  • Manage samples/materials (R&D and GMP), coordinate and document sample transfers to ensure traceability, and regularly communicate with sample owners to forecast demand. Work with the Lab Manager/Supervisor to allocate storage and laboratory space.

  • Develop training modules and provide training on equipment use, laboratory procedures/methods, and laboratory use/safety to the laboratory users.

  • Support the Laboratory and Device Teams in data review, analysis, and interpretation.

  • Identify and Report out of specification results, data, and atypical/unexpected events that occur during GMP activities and support associated investigations, impact assessments and Root Cause Analysis (RCA).

Qualifications & Experience

  • B.S. degree in an engineering field (mechanical, biological, biomedical, chemical) or equivalent and

  • > 5 years of experience in the Pharmaceutical, Biotech or Medical Device industry is preferred

Technical Knowledge

  • Direct experience in developing, validating, and executing physical test methods, and authoring/reviewing procedures and protocols .

  • Experience in R&D, GLP and GMP environments is preferred, and an understanding of the differences for these environments is critical.

  • Experience in design principles (Design Controls, URs/DIRs, Design for Manufacturability) and development of test fixtures (CAD, rapid prototyping, GD&T, material selection)

  • Knowledge of Measurement System Analysis (MSA) and statistical analysis techniques (risk analysis, sample size determination, hypothesis testing, data visualization)

  • Expertise in electrical/mechanical instrumentation, data acquisition, maintenance and data integrity.

  • Familiarity with Operational Excellence Initiatives, Lean Six Sigma, 5S, Kaizen, and/or Value Stream Mapping is a plus.

  • Familiarity with tensile/torque testing systems and/or dimensional analysis/metrology equipment is highly desired.

Interpersonal Skills:

  • Must be highly organized and detail oriented.

  • Ability to conduct work on multiple projects with precision.

  • Dependable, team oriented, creative, eager to take on responsibility, and implement change.

  • Excellent verbal and written communication skills are required.

  • Ability to lead, manage, and/or train associate engineers or new lab/ device engineers.

  • A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment.

#LI-DW1

#ptd

#ptcareers

#ptd-device

Keywords: Hoffmann-La Roche Ltd, South San Francisco , Engineer II, Laboratory Operations Supervisor, Other , South San Francisco, California

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