Equipment Engineer - Biopharma/Pharma

Infotree Global Solutions; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Infotree Global Solutions is seeking an engineer to own biopharmaceutical process equipment, drive improvements, and coordinate maintenance and validation activities. The role includes supporting commissioning, qualification, and interactions with inspectors to ensure compliant operations.

You will monitor performance, lead root-cause analyses, and support new product introductions and technology transfers while aligning with SOPs and regulatory requirements.

Qualifications

• Master’s degree and 1 year of Engineering experience; OR Bachelor’s degree and 2 years of Engineering experience; OR Associate’s degree and 8 years of Engineering experience; OR High school diploma/GED and 10 years of Engineering experience.
• Bachelor’s degree in Chemical or Mechanical Engineering preferred.
• 4+ years of relevant work experience, including 2+ years in a biopharmaceutical operations/manufacturing environment.
• Experience in regulated environments (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems and processes such as change control, non-conformances, corrective and preventive actions, and qualification/validation.
• Direct knowledge of GMP biopharmaceutical production facility equipment and systems, including continuous fill lines and related equipment and systems like autoclaves, CIP, washers, WFI.

Responsibilities

• Provide system ownership for biopharmaceutical process equipment and lead improvements or upgrades.
• Coordinate maintenance activities to ensure peak system performance.
• Ensure commissioning and qualification of systems and interaction with inspectors.
• Monitor systems for performance risks and implement risk-reduction strategies.
• Troubleshoot and resolve technical issues to minimize downtime; perform RCA and CAPA where needed.
• Support new product introductions by performing engineering assessments and implementing equipment modifications.
• Ensure regional medical activities align with established SOPs.

Skills

Problem-Solving

Data-Driven Engineering

Troubleshooting

Cross-Functional Collaboration

Adaptability

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Associate’s degree with 8 years experience

High school diploma/GED with 10 years experience

Job description

Responsibilities

• Provide system ownership for biopharmaceutical process equipment.
• Identify, support, and/or lead the implementation of engineering-based improvements or upgrades to equipment and facility systems. This may include developing business cases for improvements, identifying design requirements, translating requirements into process equipment/system designs and specifications, and supporting equipment construction, startup, and validation.
• Direct and coordinate equipment maintenance activities as necessary to ensure systems operate at peak capacity.
• Ensure necessary commissioning and qualification of systems are completed and interact with inspectors as required.
• Monitor systems to identify performance risks and implement risk-reduction strategies.
• Resolve technical issues to support production and minimize downtime. This includes leading and/or supporting technical root cause analysis and implementing corrective and preventive actions.
• Support new product and technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Ensure regional medical activities align with established practices, policies, and standard operating procedures.

Basic Qualifications

• Master’s degree and 1 year of Engineering experience; OR
• Bachelor’s degree and 2 years of Engineering experience; OR
• Associate’s degree and 8 years of Engineering experience; OR
• High school diploma/GED and 10 years of Engineering experience.

Preferred Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering.
• 4+ years of relevant work experience, including 2+ years of experience in a biopharmaceutical operations/manufacturing environment.
• Experience working in a regulated environment (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems and processes such as change control, non-conformances, corrective and preventive actions, and qualification/validation.
• Direct knowledge of the design and troubleshooting of GMP biopharmaceutical production facility equipment and systems, such as continuous fill lines (washer, tunnel, isolator, cappers, and lyophilization), filling, lyophilization, inspection, and supporting equipment and systems such as autoclaves, clean-in-place (CIP) systems, washers, clean steam, and water for injection (WFI).
• Ability to analyze problems, develop and propose engineering solutions using scientific, data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, and Predictive Maintenance).
• 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

• Problem-Solving & Data-Driven Engineering: Ability to analyze problems and develop and propose engineering solutions using scientific, data-driven techniques and methodologies such as Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, and Predictive Maintenance.
• Technical Troubleshooting & Documentation: Strong technical aptitude with the ability to troubleshoot equipment, read and interpret technical documents, and understand engineering drawings, including P&IDs and electrical schematics.
• Cross-Functional Collaboration & Adaptability: Ability to collaborate effectively with diverse teams, communicate technical information clearly, and adapt to changing priorities while providing engineering support wherever needed.

Day-to-Day Responsibilities

• Provide system ownership for biopharmaceutical process equipment. Identify, support, and/or lead the implementation of engineering-based improvements or upgrades to equipment and facility systems. This may include developing business cases for improvements, identifying design requirements, translating requirements into process equipment/system designs and specifications, and supporting equipment construction, startup, and validation.
• Direct and coordinate equipment maintenance activities as necessary to ensure systems operate at peak capacity.
• Ensure necessary commissioning and qualification of systems are completed and interact with inspectors as required.
• Monitor systems to identify performance risks and implement risk-reduction strategies.
• Troubleshoot and resolve technical issues to support production and minimize downtime. This includes leading and/or supporting technical root cause analysis and implementing corrective and preventive actions.
• Support new product and technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Ensure regional medical activities align with established practices, policies, and standard operating procedures.