Lead Process Production Engineer Pharmaceutical - 3433SS

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Requirements

Process Engineer Responsibilities:

The Lead Process Engineer will support conceptual and detailed design, support in process scale-up, product development, process validation, and implementation of operational improvements that resolve manufacturing process investigations, where required. The roles may work in concert with the client or as part of a Verista team tasked with determining the root cause of manufacturing investigations. These individuals will design and execute experiments and evaluate data in support of improvement and investigations. Additionally, engineers will author technical reports in support of manufacturing process changes, optimizations, and regulatory filings (where required). Process Engineers can be assigned to various Service Lines requiring specific skills, education, and experience.

The Process Engineer will be capable of executing various Engineering or Process Sciences projects under the direction of a senior colleague/project lead.

Process/Production Engineer/Technical Resource

Resources to support Modernization facility startup efforts. Technical resource to serve as a Process/Production Engineer in support of the Rocky Mount R3 facility startup: Media Fills, Stability batches, water runs, PV batches, general production startup. Individual should have a clear understanding of Data Integrity and Change Control requirements and a clear understanding of how to interface with and navigate equipment HMI’s, to operate, troubleshoot and improve system operation. Person will be part of a focused/autonomous team to expedite startup activities and ensure success of a manufacturing area/line/process. NLT 3 years of pharma sterile injectables experience expected.

Resource will responsible for site work and will work directly with cross functional teams (automation, Ops, quality, maint, reliability, Instrumentation, Validation and MSAT), within the operations space to support technical issues, provide engineering assessments of events for process/product impact, identify and facilitate process improvements and robustness, perform data analysis for RC determination and process optimization, lead troubleshooting efforts, own and support change control, and work side by side with operations daily in support of optimization efforts for preparing the site for BAU (business as usual). BAU support will include document reviews/edits to enhance process/machine specifications, procedures, job aides, training, and improved methods of work to streamline the processes. Provide coaching and knowledge transfer to operations and maintenance personnel. Person is expected to have a strong technical understanding of relevant processes and able to understand established system matrixes for products and commodities, able to perform protocol development for engineering studies, execution of testing to define process parameters/ capability to include recipe development and parameter identification. All work to be performed according to site procedures using cGMP and good documentation practices and performed against site commitments/needs.

Personnel are expected to work 100% onsite and within the operations area (clean room areas, gowning required). Personnel may require Aseptic training/certification for the job role, so person must be able to work within cleanrooms for extended periods daily. Work will include 12-hour shift coverage working a 3-2-3 work schedule in support of multiple shifts of operations. Resource is expected to have a solid understanding of mechanical systems, system controls and instrumentation. Persons will be expected to help build knowledge management systems/engineering playbooks as well as use of OsiPi to build dashboards for their respective areas of support