Senior Engineer - Biotech Facilities & Engineering (JP7786)
Thousand Oaks, CA
: 12 months with likely extensions
Job posting date
Note: Onsite Essential
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
The Sr. Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical supply organization at the cleint. The group’s mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably.
- Candidates will be working on site.
- Must have strong, recent experience within Pharma or Biotech Industry - no exceptions.
- Must have trouble shooting of equipment day to day & continuous on going plant support experience.
- Must have experience with autoclave, washers or lyophilization.
- Must have experience with top 3 must have skills
- Doctorate or Master Degree - 3 years of engineering experience or
- Bachelors Degree - 5 years of engineering experience or
- Associate Degree - 10 years of engineering experience
Top Must have Skill Sets:
- 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 in proper working order.
- 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.
- Providing troubleshooting support to 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 systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
(Please be sure to highlight in resume)
1. 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.
2. 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. Experience with Lyophilizers a plus.
3. 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.)
Employee Value Proposition:
- Support startup and commissioning of a new vial line.
- Once startup is complete support operation of the vial line.
- Respond to equipment issues in the manufacturing plant.
- Provide equipment expertise to troubleshoot and support investigations.
- Support equipment/process improvements.
Opportunity to troubleshooting equipment in operating GMP plant, exposed to QA & Manufacturing Engineer, exposure to different leadership.
Candidate can't only have Startup/commissioning/validation experience.
Lack of engineering degree, Pharma or Biotech experience & top 3 must have skills.
Phone Interview & Skype Interview.
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.