Engineer-Autoclaves

2 weeks ago

Thousand Oaks, United States Infotree Global Solutions Full time

ONSITE THOUSAND OAKS

Flexible availability, schedule is 7am - 4pm need to be open to after hours calls.

Ideal candidate: Highly motivated individual, system owner Mechanical and electrical engineering background. Pharmaceutical industry manufacturing maintenance engineering and not operations side. 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.

The Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical Supply organization at client. The groups 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 Thousand Oaks site.

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.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Preferred Qualifications:

Bachelors 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

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