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Validation Engineer III
Ref No.: 17-15188
Location: South San Francisco, California
Job Title: Validation Engineer III
Job Company: Major BioPharma
Job Dept: Device Development
Job Category: Validation & Commissioning

Job Location: SSF, CA 94080
Job Duration: 1 year contract; Special Project

Job Description:

Quality Systems Compliance:
  • Understand, implement and maintain COMPANY Pharma Quality Policy and Pharma Quality System (PQS) in the department.
  • Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
  • Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
  • Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
  • Ensure compliance of training to PQS and job-related requirements.
  • Support the laboratory lead in preparing communications for internal review committees.

Design Control:
  • Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, comuter system validation, design verification, failure modes effects and analysis, risk management plans, and change management plans.
  • Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
  • Participate in hazards analyses and design assessments and reviews.
  • Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.

The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization. This objective will be accomplished by executing activities in the areas of:

Device Engineering:
  • Plan, lead, and execute computer system validation projects.
  • Serve as SME for 21 CFR Part 11, Computer System Validation (CSV), and IT Compliance applicable to GMP environments.
  • Work with limited direction. Provide guidance and coordinate work activities with other personnel.
  • Plan, implement, and coordinate commissioning and qualification of computer systems (e.g. hardware, software, and accessory systems) for use in regulated and non-regulated operations.
  • Review laboratory requirements and define procedures for instrument and data management.
  • Implement 21 CFR Part 11 for new and existing testing computerized laboratory instruments and execute qualification in compliance with cGMP requirements.
  • Author commissioning and qualification of CSV documents through system life cycle. This includes deliverables such as user requirements, design specifications, qualification protocols, reporting, and support documentation (i.e. traceability matrices, SOP, etc.).
  • Support installation activities when needed to ensure proper systems startup and recommend changes to improve system design.
  • Regularly interface with staff and leaders in Pharmaceutical Development, Quality and Regulatory Affairs
  • Regularly interact with external development partners and equipment suppliers

Desired Skills:
The Computer System Validation Engineer will be responsible for providing development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at COMPANY.

The candidate has technical expertise in development, qualification, and maintainenance of computer systems controlling laboratory instruments, including instruments used in the development and commercialization of drug-device combination products, and provides technical leadership to support engineering, scientific, and manufacturing activities within COMPANY'S device development programs, including manual injection systems, automated injection systems, and interfaces with pre-filled syringes and cartridges.

The Computer System Validation Engineer will be assigned responsibilities to perform tasks and will assist Device Engineers and Laboratory staff in identifying and defining critical project steps, and develop practical and thorough solutions to problems.

The candidate will work with general direction and may also supervise staff members.
Work collaboratively across functions with quality, development, IT, and vendors

The work is reviewed upon completion.

Technical Knowledge:
  • Strong knowledge of FDA regulations and experience in implementing 21 CFR Part 11.
  • Knowledge of CSV requirements and procedures for laboratory instrumentation and instrument qualification (IQ/OQ/PQ).
  • Working knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems).
  • Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, etc..
  • Six Sigma (Green/Black Belt): DMAIC and DFSS.

Interpersonal Skills:
  • Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable.
  • Excellent oral and written communication skills are required.
  • Team oriented, dependable, self-starter.
  • Highly organized and detail oriented.

Education:
  • B.S, M.S, Ph.D or advanced degree in Science or Engineering.
  • At least 5 years of experience computer system validation.