Engineer Senior

Summary: This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Thousand Oaks (ATO). The senior engineer works in partnership with the automation, maintenance, and manufacturing teams to develop and oversee the reliability of equipment while driving safety and quality compliance. The engineer will provide data to support business cases and long term strategy. Day to Day Responsibilities: Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment. Be accountable for manufacturing equipment reliability. Suggest design modifications to address risks and design in quality and safety. Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation. 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. Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order. Monitor systems to identify performance risks and implement risk reduction strategies. Providing trouble shooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. Top 3 Must Have Skill Sets: 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. Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, 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., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.). Experience/Education: Bachelor Engineering process mechanical degree and 5 years of experience. Compensation: The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements). Benefits and Ancillaries: Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

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