Senior Process Engineer - Holly Springs, NC

Senior Process Engineer - Holly Springs, NC

Senior Process Engineer

What You Will Do:

Let's do this. Let's change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up. Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment. Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order. Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations. Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors. System guidance to identify performance risks and implement risk reduction strategies. Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

What We Expect Of You:

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications. Basic Qualifications: High school diploma / GED and 10 years of Engineering experience OR Associate's degree and 8 years of Engineering experience OR Bachelor's degree and 4 years of Engineering experience OR Master's degree and 2 years of Engineering experience OR Doctorate degree Preferred Qualifications: Bachelor's degree in Chemical or Mechanical Engineering 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment with a focus on Upstream unit operations Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc. Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.) Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation Understanding of safety requirements working in a GMP Biopharmaceutical Production facility. Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork Collaborative teammate prepared to work in and embrace a team based environment that relies on communication for effective decision-making Strong leadership, technical writing, and communication/presentation skills Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage Ability for domestic/international travel (~10%)