Jr/Mid Validation Engineer

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

Job Description:

Validation - Facility/Equipment/Utility Validation / 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 Validation Engineer/Specialist I and II is an entry to mid level position primarily responsible for execution of qualification and validation activities to drive overall quality and compliance at the assigned client's site. The Validation Engineer/Specialist I and II may be part of a larger team executing a specific project scope or may act in a staff augmentation role by executing a variety of validation deliverables. Client site work includes validation support for installations and modifications of biomanufacturing equipment, utility systems, computerized systems, laboratory instrumentation, and facilities. Client sites are located in the greater Boston, MA area. Key skills include creating commissioning and qualification documentation (commissioning and I/OQ protocols), executing commissioning and qualification activities, authoring summary reports, and supporting any other validation needs related to the project. Essential Duties and Responsibilities

• Participate in project teams executing various validation projects under the direction of a project manager or validation lead.
• Generate/Revise Commissioning, Installation, Operational and Performance Qualification (IQ/OQ/PQ) Protocols for various life science lab, computer system, manufacturing and packaging equipment and utilities.
• Execute Commissioning, Installation, Operation and Performance Qualification Protocols for various life science lab, computer system, manufacturing and packaging equipment and utilities.
• Participate in issue identification, investigation and mitigation. Generate test problem reports.
• Generate associated validation summary reports.
• Provide routine progress and issue update to project team.
• Perform temperature mapping and other miscellaneous validation activities.
• Participate in client Validation teams in executing routine Validation deliverables in a staff augmentation role. Required Education and Experience
  • BS in chemical, biomedical or biochemical engineering, biological sciences, or related field/experience.
  • 0-5 years relevant industry experience for Validation Engineer/Specialist I
  • 5-10 years relevant industry experience for Validation Engineer/Specialist II
  • Working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices.
  • 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
    • Previous experience working in a cGMP manufacturing environment
    • Previous experience writing and executing GMP documentation, preferably Validation protocols such as Installation, Operation and Performance Qualification documents.
    • Understanding of GMP production facility utilities and their application, such as Water for Injection (WFI), Cleanroom Environments (HVAC), Clean Steam and process gases
    • Understanding of process fundamentals for at least one of the following:
    • o Small molecule chemical synthesis
    • o Monoclonal antibody or protein biomanufacturing
    • o Cell therapy and regenerative medicine
    • o Analytical QC laboratories
    • o Computerized Systems
    • o Packaging
    • Understanding of quality systems such as change control and discrepancy investigations

Keywords: Delta Project Management, Inc., Boston , Jr/Mid Validation Engineer, Engineering , Boston, Massachusetts