Process Engineer - Solution Prep, Upstream, and Downstream

About the role

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.

Responsibilities

• Support the commissioning and qualification of manufacturing systems in alignment with GMP requirements and interact with regulatory inspectors.
• Ensure systems are installed and operate safely and comply with pertinent environmental health/safety practices, rules, and regulations.
• Support commissioning and qualification of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulations.
• Interact with regulatory inspectors as a manufacturing systems owner to communicate and demonstrate appropriate regulatory compliance of operating systems.
• Aid in new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Provide systems support for biopharmaceutical process equipment.
• Assist in identifying and implementing engineering-based improvements or upgrades to equipment or facility systems.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
• Provide system guidance to identify performance risks and implement risk reduction strategies.
• Provide problem-solving support to reduce production downtime. This includes supporting technical root cause analysis and implementation of corrective/preventive action.
• Provide rotational on-call support and/or shift support based on business needs to ensure 24x7 day-to-day reliability of Solution Prep, Upstream and Downstream systems for plant operations.
• On-site and up to 10% domestic/international travel.

Requirements

• Masters degree
• OR
• Bachelor's degree and 2 years of Engineering experience
• OR
• Associates degree and 6 years of Engineering experience
• OR
• High school diploma/GED and 8 years of Engineering experience

Preferred Qualifications

• Bachelor's degree in Chemical or Mechanical Engineering or similar engineering discipline.
• 3+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment.
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Solution Prep, Upstream, and Downstream purification equipment such as weigh and dispense equipment, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, and UFDF skids 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.

Qualifications

• Basic Qualifications:
• Masters degree
• OR
• Bachelor's degree and 2 years of Engineering experience
• OR
• Associates degree and 6 years of Engineering experience
• OR
• High school diploma/GED and 8 years of Engineering experience

Benefits

We offer competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Pay

Commensurate with experience

Schedule

N/A