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Mid/Senior Validation Engineer (Process Validation - Biologics)

Company: Delta Project Management, Inc.
Location: San Francisco
Posted on: February 25, 2021

Job Description:

Mid/Senior Validation Engineer (Process Validation - Biologics) Engineering and Facilities - Process Engineering / Delta PM was founded in 2006 with a mission to deliver successful outcomes for its employees, our clients, and patients through exceptional relationships, collaboration, and execution. As a company dedicated to the Life Sciences, we have the ability to impact lives in a positive and meaningful way. We provide Validation, Project Management and Quality Assurance solutions that enable our clients to develop and deliver drug products to their patients with quality and speed. Delta PM has established itself as a top provider of staff and expertise in the Life Sciences Industry, and we now count 8 of the top 10 largest biopharma companies in the San Francisco Bay Area as our customers, and in total work with nearly 30 clients from coast to coast. Our goal is to deliver the best technical expertise with a focus on fostering long-term relationships based on trust, and to always go above and beyond to reach project milestones and objectives. Professional growth for our employees is very important here at Delta PM, and this creates a lot of great opportunities for our team members. We are looking for "Deltoids" who embody our core values of being people-focused, and demonstrating integrity and excellence in their work on a daily basis. If you enjoy working in a collaborative, fast-paced, and continuously growing environment, we welcome a conversation to let you know what makes us different from the rest. Come join our team! The Process Engineer II / Senior Process Engineer will play a key role in providing technical knowledge, experience, and expertise to our clients, ensuring successful manufacture of therapeutics. The primary focus of the Process Engineer will be to support conceptual and detailed design, support in process scale-up, product development, and process validation, tech transfer, and implementation of operational improvements that resolve manufacturing process investigations, where required. This role may work in concert with the client or as part of a DPM team tasked with determining the root cause of manufacturing investigations. This individual will design and execute experiments and evaluate data in support of improvement and investigations. Additionally, the engineer will write technical reports in support of manufacturing process changes, tech transfer, optimizations and regulatory filings. Essential Duties and Responsibilities

  • Responsible for recommending validation strategy, leading the generation, execution and reporting of biologics process validation deliverables and supporting documentation using a risk-based approach.
  • Participate in project teams executing various technology transfer, process change, scale-up, and process validation projects.
  • Generate and revise biologics Process Validation (PV) and Product Performance Qualification (PPQ) or Continuous Process Verification (CPV) for small scale clinical-manufacturing process and large-scale commercial manufacturing process including continuous or batch cell culture process and purification process.
  • Support failure investigations and implementation of solutions (corrective and preventive actions) that solve manufacturing and product problems, follow-up on corrective and preventive actions to determine their effectiveness and suitability, and prepare written reports on these activities in a timely fashion.
  • Participate in Risk Assessments, Change Controls, CAPA, and Engineering Document generation.
  • Provide technical guidance and leadership to junior Validation staff. Required Education and Experience
    • Bachelor's degree in chemical, biomedical or biochemical engineering, biological sciences, or related field/experience.
    • 5-10 years relevant industry experience.
    • Must have direct Process Validation experience in biologics (cell culture and purification)
    • Expert understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.
    • Hands-on experience in biological process validation activities including drug substance manufacturing processes, drug product filling processes, process simulations (media fills), filtration, mixing, sterilization, lyophilization, and completion of validation risk assessments and evaluations.
    • Demonstrated experience writing and executing GMP documentation and Validation protocols such as Installation, Operation, and Performance Qualification documents.
    • Coordination and participation of process validation activities involving cross-functional, multi-departmental teams including: Manufacturing (contract), Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
    • Ability to think critically and demonstrate troubleshooting and problem-solving skills.
    • Able to function efficiently and independently in a fast paced, changing environment.
    • Able to function and contribute as part of a team.
    • Possess excellent interpersonal, verbal, and written communication skills. Preferred Education and Experience
      • Experience with various stages of clinical and commercial manufacturing in a Quality and/or Process Sciences role.
      • Background in development and MSAT is a plus!

Keywords: Delta Project Management, Inc., San Francisco , Mid/Senior Validation Engineer (Process Validation - Biologics), Engineering , San Francisco, California

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