Engineer

Thousand Oaks, CA 91320

Posted: 05/09/2024 Job Number: 39132

Job Description


Engineer


Top 3 Must Have Skill Sets:
  • Troubleshooting skills
  • Mechanical systems expertise
  • Ability to analyze problems, develop and propose engineering solutions in a scientific manner

Red Flags:
  • lack of Mechanical systems knowledge
  • If they cant commit to being onsite

Summary:

The Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical Supply organization at our company. 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 our 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.

Basic Qualifications:
  • 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

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

 

Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.