Engineer – GMP Drug Product Manufacturing Equipment & Reliability (JP16083)

3key Consulting, Inc.; Thousand Oaks (CA); Sur place; USD 56 000 - 63 000; Plein temps

Résumé du poste

3 Key Consulting, Inc. is seeking an Engineer for GMP drug product manufacturing equipment and reliability at our Thousand Oaks site. Contract role supporting Facilities & Engineering within Manufacturing and Clinical Supply.

The engineer will help implement improvements, coordinate maintenance, and ensure qualification processes are completed with inspection readiness. The role requires a strong background in biopharma equipment, data-driven problem solving, and collaboration across teams.

Qualifications

• Doctorate, MS, BS, AS or HS with years of Eng experience as listed.
• Experience with GMP/biopharma environments is preferred.
• Ability to read technical docs and use P&IDs and electrical drawings.
• Data-driven problem solving: RCA, SPC, Six Sigma, predictive maintenance.

Responsabilités

• Provide system ownership for biopharmaceutical process equipment and identify/lead improvements.
• Coordinate maintenance to keep systems at peak capacity.
• Ensure commissioning/qualification of systems and interaction with inspectors.
• Monitor performance risks and implement risk reduction strategies.
• Lead root cause analyses and implement corrective and preventive actions.

Connaissances

RCA & SPC

P&IDs & drawings

Cross-functional collab

Formation

Doctorate

MS + 1y Eng

BS + 2y Eng

AS + 8y Eng

HS diploma +10y Eng

Description du poste

Engineer – GMP Drug Product Manufacturing Equipment & Reliability (JP16083)

Location: Thousand Oaks, CA. 91320

Employment Type: Contract

Business Unit: F&E Drug Product Supply

Duration: 1+ year (with likely extensions and/or conversion to permanent)

Posting Date: 11/5/26

Pay Rate: $41- $46/hour W2

Notes: Only qualified candidates need apply. Standard Standard 8am-5pm local hours M-F

3 Key Consulting is hiring an Engineer – GMP Drug Product Manufacturing Equipment & Reliability for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description: 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 into Senior Manager of Engineering supporting drug product supply at our client’s Thousand Oaks, CA, site.

Why is the Position Open?

Supplement additional workload on team

Top Must Have Skills:

• 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.).
• Technically inclined and able to troubleshoot equipment, read and fully understand technical documents, and use P&IDs and electrical drawings.
• Collaborate effectively with diverse teams and adapt to provide support where needed.

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.

Basic Qualifications:

• Doctorate degree
• Or Master’s degree and 1 years 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 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

Red Flags:

No technical or engineering backgroud

Interview process:

• Initial screening with Hiring manager (Teams)
• Follow up interview with team member(s) (Teams)