Department: Azzur IT, LLC
We at Azzur Group are looking for a Process Validation Engineer to immediately join our Azzur Consulting: Philly Team. The Process Validation Engineer is an FTE project based role. The Process Validation Engineer defines qualification & validation strategies and develops the necessary documents (e.g. plans, protocols, and reports).
- Manage the execution of process validation activities including designing protocols and studies, investigating protocol deviations and acceptance criteria failures, and compiling final summary reports.
- Support the implementation of process control strategies. Ensure control strategy content is developed to facilitate regulatory submissions including IND, IMPD, MAA, and BLA.
- Review and maintain the content of technical lifecycle documentation (i.e. QTPP, Process Parameter reports, Material Attribute reports, Control Strategy Documents, etc) ensuring compliance with the validated state of the process.
- Lead the development of strategies, plans, and protocols for Process Performance Qualification (PPQ) of drug product manufacturing processes. Oversee the execution of PPQ activities and develop PPQ reports. Ensure that PPQ activities are documented compliantly.
- Apply risk management tools and principles throughout the process validation lifecycle.
- Stay current with industry trends and standards (PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
· Education: BS/BA degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering is a plus.
· 4-7 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry. 5 years of direct process engineering experience is a plus.
· Experienced in the areas of Process Equipment Design, specifically with isolators, autoclaves, parts washers and fill-finish equipment. Demonstrates a solid understanding of cleaning validation and sterilization.
· Excellent written and verbal communication skills; excellent technical writing skills.
· Strong interpersonal skills and the ability to work in a team environment.
· Ability to work effectively in a fast-paced multitasking environment.
· Strong working knowledge of FDA and cGMP regulations and documentation practices.
· Proficient in Microsoft Word, Excel, PowerPoint.
·Working for multiple clients throughout the region.
Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.