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Principal Engineer, Process/Equipment Validation

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Genentech

21d ago

  • Job
    Full-time
    Expert Level
  • Engineering
  • Hillsboro

AI generated summary

  • You must have 12+ years of pharma/biotech industry experience, hands-on aseptic processing equipment knowledge, cGMP expertise, project management skills, validation experience, and excel in cross-functional collaboration for a Principal Engineer role at Genentech.
  • You will lead validation activities, manage equipment lifecycle, oversee projects, ensure compliance, conduct investigations, prepare documentation, stay current on regulations, and mentor validation engineers.

Requirements

  • BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 12 years experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is required.
  • Experience in the pharma/biotech industry is required.
  • Hands-on experience in the design, selection, installation, and validation of equipment used in aseptic processing.
  • Knowledge of cGMPs or equivalent regulations. Experience working in a regulated environment, knowledge of cGMPs, and a strong understanding of the regulatory requirements specific to aseptic processing.
  • Working knowledge of formulation, filling, and packaging, equipment qualification in a regulated environment is required.
  • Experience in managing equipment and process related projects, including commissioning and qualification, new product introduction, technology transfers.
  • Demonstrated experience in writing and reviewing SOPs and protocols for accuracy, traceability, and compliance.
  • Experience in performing and leading validation studies within the pharmaceutical and biotechnology industry.
  • Experience working collaboratively with cross-functional teams, including development, operations, quality assurance, automation engineering, and maintenance.
  • Experience in driving continuous improvement initiatives related to process, equipment, and quality systems.
  • Demonstrated project management skills.
  • Operational excellence and industrial engineering skills are a plus.
  • Professional level written and oral communication skills.

Responsibilities

  • Develop and manage the detailed project plans and timelines for the execution of validation activities ensuring compliance with Roche standards and regulatory requirements.
  • Manage the qualification lifecycle of equipment and processes including design, installation, operational, performance, continuous qualification and decommissioning.
  • Manage projects and serve as technical lead for the introduction of new equipment and/or products within predetermined timelines, financial forecasts and compliance requirements.
  • Set the strategic, timeline and execution of complex initiatives, studies, and projects while ensuring a robust process, alignment between disciplines and functions and cost saving.
  • Procure and manage external resources and materials to support validation deliverables.
  • Understand and consider process knowledge to ensure equipment and process changes don't impact product quality.
  • Lead complex investigations, root cause analysis, complaint trend analysis, and other related post-market surveillance activities.
  • Oversight of validation change control management, deviation management, risk management for validated equipment, utilities, processes and facilities.
  • Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities.
  • Incorporate new regulations into manufacturing processes and validation program ensuring continued compliance.
  • Prepare, review and approve relevant sections of regulatory submissions.
  • Lead presentation of the validation program and maintenance of the validated state during periodic audits and regulatory inspections.
  • Incorporate new manufacturing methods, equipment and processes to improve existing operations.
  • Engage and partner with other network functions and industrial colleagues to progress process designs and qualification.
  • Provide input into investigations and change control with potential impact to the site risk profile.
  • Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.
  • Lead and mentor validation engineers and train individuals on practices and procedures.

FAQs

What are the main responsibilities of a Principal Engineer, Process/Equipment Validation?

The main responsibilities of a Principal Engineer, Process/Equipment Validation include setting the strategic direction for validation programs, managing project plans and timelines, leading validation activities such as Commissioning and Qualification, Performance Qualification, Cleaning Validation, Process Validation, and Revalidation, overseeing equipment and process qualification lifecycle, managing the introduction of new equipment and products, leading investigations and root cause analysis, preparing validation documentation, and ensuring compliance with regulations and standards.

What qualifications and requirements are necessary for a Principal Engineer, Process/Equipment Validation?

To qualify for a Principal Engineer, Process/Equipment Validation role, candidates should have a BS/MS in chemical, biochemical engineering or related field, with at least 12 years of experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services in the pharma/biotech industry. They should have hands-on experience in aseptic processing, knowledge of cGMPs, expertise in equipment qualification, project management skills, and excellent written and oral communication skills.

Is remote work possible for a Principal Engineer, Process/Equipment Validation?

This position is not eligible for full-time remote work arrangements.

Science & Healthcare
Industry
10,001+
Employees
1976
Founded Year

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