Engineer II, Laboratory Operations Supervisor
Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 6, 2021
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
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
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
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
Develop training modules and provide training on equipment use,
laboratory procedures/methods, and laboratory use/safety to the
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
Direct experience in developing, validating, and executing
physical test methods, and authoring/reviewing procedures and
Experience in R&D, GLP and GMP environments is preferred,
and an understanding of the differences for these environments is
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.
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
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
Keywords: Hoffmann-La Roche Ltd, South San Francisco , Engineer II, Laboratory Operations Supervisor, Other , South San Francisco, California
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