Process & Equipment Reliability Engineer – Biopharmaceutical Drug Substance Manufacturing - (JP15977)

3key Consulting, Inc.; Thousand Oaks (CA); Sur place; USD 85 000 - 96 000; Plein temps

Résumé du poste

3 Key Consulting, Inc. is hiring a Process & Equipment Reliability Engineer for Biopharmaceutical Drug Substance Manufacturing in Thousand Oaks, CA. This contract role supports system reliability and optimization with a 14+ month engagement, onsite at the client site.

Responsibilities include analyzing systems, conducting root cause analysis, leading improvement projects, and coordinating with cross-functional teams in a regulated biotech environment to ensure compliant and safe operations.

Qualifications

• Degree in engineering field or hands-on experience with mechanical, chemical, electrical, or related engineering.
• Experience investigating equipment or system problems using data and maintenance history.
• Experience producing clear technical records in a regulated environment.

Responsabilités

• Support system reliability and optimization, identify risks, and implement reduction strategies.
• Assist with technical investigations, root cause analysis, and equipment troubleshooting.
• Analyze data and help develop engineering solutions using data techniques (e.g., SPC, Six Sigma).
• Support new technology introductions through engineering assessments and equipment mods.
• Collaborate with cross-functional teams to communicate findings and drive solutions.
• Provide onsite day-to-day technical support for equipment and process issues.

Connaissances

Facilities engineering fundamentals

Equipment troubleshooting & data分析

Formation

Master's degree or Bachelor's degree with experience

Description du poste

Process & Equipment Reliability Engineer – Biopharmaceutical Drug Substance Manufacturing - (JP15977)

• Thousand Oaks, CA
• Biotech/Pharmaceutical

Job Title: Process & Equipment Reliability Engineer – Biopharmaceutical Drug Substance Manufacturing - (JP15977)

Location: Thousand Oaks, CA. 91320

Employment Type: Contract

Business Unit: F&E Drug Substance Supply

Duration: 14+ months (with likely extensions and/or conversion to permanent)

Posting Date: 10/14/26

Pay Rate: $41 - $46/hour W2

Notes: Only qualified candidates need apply. Onsite. Local candidates preferred.

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

Job Description:

Support system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts, including identifying cycle reduction time opportunities, efficiency gains, and yield improvement opportunities.

Why is the Position Open?

Supplement additional workload on team

Top Must Have Skills:

• Facilities or process engineering fundamentals — Can interpret P&IDs, equipment specifications, and basic engineering drawings; apply engineering principles to systems such as bioreactors, UFDF, clean in place, autoclave. Look for a degree or hands‑on experience in mechanical, chemical, electrical, or a related engineering field.
• Equipment troubleshooting and data analysis — Can investigate equipment or system problems using operating data, maintenance history, and structured problem‑solving; identify likely causes and recommend practical next steps. Relevant experience may include internships, labs, manufacturing, maintenance, or project work.
• Technical documentation in a regulated or safety‑focused environment — Can produce clear technical records and follow procedures, safety requirements, and change controls. Biotech, pharmaceutical, medical device, food, or other regulated‑industry experience

Day to Day Responsibilities:

• Support system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts, including identifying cycle reduction time opportunities, efficiency gains, and yield improvement opportunities.
• Support technical investigations, root cause analysis, and equipment troubleshooting activities. Apply structured problem‑solving methodologies with guidance.
• Analyze data and assist in developing engineering solutions using data techniques and methodologies (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)
• Support new technology introductions by assisting with engineering assessments, equipment modifications, and execution of engineering runs.
• Collect, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity
• Provide onsite day‑to‑day technical support for equipment and process troubleshooting.
• Apply process engineering principles to support the design, specification, installation, startup, and validation of process equipment and systems
• Assists with project activities by performing engineering studies and assessments for process equipment systems
• Translate user and process requirements into engineering documentation and support design development in alignment with standard engineering practices.
• Communicate effectively with supervisors, cross‑functional teams, and support staff to elevate issues and contribute to solutions.
• Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations.

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

Red Flags:

Casual attitude toward safety or documentation, can't explain their own technical work

Interview process:

Phone/Teams interview. Interviews to start immediately.