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Mid/Senior Validation Engineer (Process)

Company: Delta Project Management, Inc.
Location: Cambridge
Posted on: May 3, 2021

Job Description:

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 II / Senior Validation Engineer will play a key role in providing technical knowledge, experience, and expertise to our clients, ensuring the successful manufacture of therapeutics. The primary focus of the Validation Engineer (Process) will be to support biologics Product Performance Qualification (PPQ) or Continued Process Verification (CPV). This role may work in concert with the client or as part of a DPM team. Essential Duties and Responsibilities Responsible for recommending validation strategy, leading the generation, execution and reporting of deliverables including 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 Product Performance Qualification (PPQ) or Continued Process Verification (CPV). Generate and revise GMP documentation and Validation protocols such as Installation, Operation, and Performance Qualification (IQ, OQ, PQ) for biologics process equipment. 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. 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. Experience in biologics (cell culture and purification) Product Performance Qualification (PPQ) or Continued Process Verification (CPV). Demonstrated experience writing and executing GMP documentation and Validation protocols such as Installation, Operation, and Performance Qualification documents. 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 Expert understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements. 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., Cambridge , Mid/Senior Validation Engineer (Process), Other , Cambridge, Massachusetts

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