Engineer (Process equipment, C&Q)

Infotree Global Solutions; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Infotree Global Solutions is seeking an Engineer to join Client Thousand Oaks' Facilities & Engineering team. The role focuses on biopharmaceutical process equipment, system ownership, and continuous improvement in a regulated environment.

The position involves 4x10-hour shifts with weekend coverage, heavy emphasis on troubleshooting, commissioning, qualification, and risk mitigation to ensure reliable operations across fill lines, CIP, autoclaves, and related systems.

Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering.
• 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment.
• Experience in regulated environments (e.g. cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes.
• Knowledge of GMP Biopharmaceutical Production facility equipment/systems (e.g., continuous fill lines, CIP, autoclaves, lyophilization).
• Ability to analyze problems and propose engineering solutions using data-driven methods (RCA, SPC, Six Sigma).
• Experience applying engineering principles to system modifications and capital projects.

Responsibilities

• Provide system ownership for Biopharmaceutical process equipment and lead improvements.
• Coordinate equipment maintenance to ensure peak capacity.
• Ensure commissioning and qualification of systems with inspectors as needed.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Lead/root cause analysis and implement corrective/preventive actions.
• Support new product/technology introductions by engineering assessments and equipment modifications.
• Align regional medical activities with SOPs.

Skills

GMP knowledge

Root Cause Analysis

Process equipment troubleshooting

Data-driven decision making

Capital project execution

Education

Bachelor’s degree in Chemical or Mechanical Engineering

Job description

Provide shift coverage on a four-day, 10-hour-per-day schedule, including at least one weekend day.

Shift work, 4X10 hrs. including at least one weekend day.

The Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical Supply organization at Client . The group’s mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report into Senior Manager of Engineering supporting drug product supply at Client Thousand Oaks site.

Preferred Qualifications:

• Bachelor’s degree in Chemical or Mechanical Engineering
• 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
• 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 continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, 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 applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects

Top 3 Must Have Skill Sets:

• Able to work flexible hours: Provide shift coverage on a four-day, 10-hour-per-day schedule, including at least one weekend day.
• Operate independently, adapt quickly, and learn effectively in a fast-paced environment.
• Have engineering background and able to perform and coordinate complex troubleshooting

Day to Day Responsibilities:

• 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.
• Directing and coordinating equipment maintenance as necessary to ensure systems are working at peak capacity.
• Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Solving issues to support and 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.
• Ensure regional medical activities align with practices, policies and standard operating procedures.