Process & Equipment Reliability Engineer – Biopharmaceutical Drug Substance Manufacturing - (JP15977)
About The Position
3 Key Consulting is hiring a Process & Equipment Reliability Engineer for a consulting engagement with a leading global biopharmaceutical company. The role supports biopharmaceutical drug substance manufacturing in Thousand Oaks, California, and is an onsite contract engagement lasting 14 or more months, with likely extensions and/or conversion to permanent employment. The engineer will support system reliability and operational optimization, identify equipment and process performance risks, and implement risk-reduction strategies. The role also contributes to cycle-time reduction, efficiency and yield improvement, technical investigations, root cause analysis, equipment troubleshooting, engineering assessments, and new technology introductions. The position provides day-to-day onsite technical support and assists with design, specification, installation, startup, and validation of process equipment and systems. The position is open to supplement additional workload on the team. Candidates should be able to interpret engineering drawings and equipment specifications, investigate system problems using data and maintenance history, and produce clear technical documentation while following procedures, safety requirements, and change controls.
Requirements
- Meet one of the following education and experience combinations: a master's degree; a bachelor's degree and 2 years of experience; an associate degree and 6 years of experience; or a high school diploma/GED and 8 years of experience.
- Knowledge of facilities or process engineering fundamentals, including the ability to interpret P&IDs, equipment specifications, and basic engineering drawings.
- Ability to apply engineering principles to systems such as bioreactors, UFDF, clean-in-place systems, and autoclaves.
- Ability to investigate equipment or system problems using operating data and maintenance history, identify likely causes, and recommend practical next steps.
- Ability to produce clear technical records and follow procedures, safety requirements, and change controls.
- Ability to communicate effectively with supervisors, cross-functional teams, and support staff.
- Commitment to safety and thorough technical documentation.
Nice To Haves
- Degree or hands-on experience in mechanical, chemical, electrical, or a related engineering field.
- Experience in a biotechnology, pharmaceutical, medical device, food, or other regulated industry.
- Relevant experience from internships, laboratories, manufacturing, maintenance, or project work.
Responsibilities
- Support system reliability and operational optimization efforts.
- Identify system performance risks, such as single points of failure or obsolescence, and implement risk-reduction strategies.
- Lead and execute improvement efforts, including identifying cycle-time reduction, efficiency, 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 techniques such as Statistical Process Control, Six Sigma, and predictive maintenance analysis.
- Support new technology introductions by assisting with engineering assessments, equipment modifications, and engineering runs.
- Collect, organize, analyze, and present results for operational issues and small-scope engineering projects.
- 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.
- Assist 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 with supervisors, cross-functional teams, and support staff to escalate issues and contribute to solutions.
- Support a safe working environment by following applicable environmental health and safety practices, rules, and regulations.
