Engineer – Bioprocessing Systems/Equipment - (JP13262)

3 Key Consulting • Thousand Oaks, CA

1d • $38 - $42 • Onsite

About The Position

The qualities and characteristics we are looking for in candidates include: Fast learner Strong critical thinking skills Ability to handle stress well Technically inclined with skills in electro-mechanical systems. Candidates must show an engineering mindset, particularly those who use the scientific method to solve issues and provide examples of projects they have worked on. Regarding the minimum education and experience requirements, a BA in Engineering, whether it be Mechanical, Industrial, or Electrical Engineering, is suitable for this role. As for non-negotiables, candidates must have a degree in an engineering-related field and must be flexible with their working hours. Our 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 of our 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 to the Senior Manager of Engineering supporting drug product supply.

Requirements

• Fast learner
• Strong critical thinking skills
• Ability to handle stress well
• Technically inclined with skills in electro-mechanical systems
• Candidates must show an engineering mindset, particularly those who use the scientific method to solve issues and provide examples of projects they have worked on
• BA in Engineering, whether it be Mechanical, Industrial, or Electrical Engineering, is suitable for this role
• Candidates must have a degree in an engineering-related field and must be flexible with their working hours
• 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
• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Nice To Haves

• 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.
• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level