Engineer I - Multiple Shifts

• 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
• Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate 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
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
• Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations
• Provide technical mastery and problem-solving leadership to proactively reduce production downtime
• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment
• Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments, identifying gaps and owning their remediation, implementing equipment modifications, and supporting engineering runs

High school diploma / GED and 8 years of Engineering/Maintenance experience OR Associate’s degree and 6 years of Engineering/Maintenance experience OR Bachelor’s degree and 2 years of Engineering/Maintenance experience OR Master’s degree

• Bachelor’s degree in Chemical or Mechanical engineering
• 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.
• Experience with equipment and facility control systems operation, logic, and troubleshooting
• 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
• Strong leadership, technical writing, communication/presentation skills and the ability to work with minimum direction
• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment
• Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information
• Ability to function within cross-functional teams and embrace a team-based environment
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
• Understanding of the execution process 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
• Great teammate prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible