Engineer Biotech Equipment and Facilities JP11899
Engineer Biotech Equipment and Facilities JP11899
Posted on :
05-04-2025
Employer Active
1 Vacancy
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Hourly Salary
$ 38 - 42
Vacancy
1 Vacancy
Posted on :
05-04-2025
Job Description
Job Title: Engineer Biotech Equipment and Facilities (JP11899
Location: Thousand Oaks CA. 91320
Business Unit: F&E Drug Substance Supply
Employment Type: Contract
Duration: 1 year(s) (with possible extensions)
Rate: $38 $42/hour W2
Posting Date: 10/18/23
Notes: Only qualified candidates need apply. Fully onsite
3 Key Consulting is recruiting an Engineer Biotech Equipment and Facilities for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at client in Thousand Oaks. The engineer works in partnership with the automation maintenance project management corporate engineering and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy. The Engineer role will provide direct engineering technical support as follows:
Top Must Have Skill Sets:
Day to Day Responsibilities:
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:
Red Flags:
Interview Process:
One phone screen/onsite interview.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Location: Thousand Oaks CA. 91320
Business Unit: F&E Drug Substance Supply
Employment Type: Contract
Duration: 1 year(s) (with possible extensions)
Rate: $38 $42/hour W2
Posting Date: 10/18/23
Notes: Only qualified candidates need apply. Fully onsite
3 Key Consulting is recruiting an Engineer Biotech Equipment and Facilities for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at client in Thousand Oaks. The engineer works in partnership with the automation maintenance project management corporate engineering and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy. The Engineer role will provide direct engineering technical support as follows:
- Model leadership behaviors and positive values to create a positive working environment.
- Be individually accountable for the consistent equipment performance
- Be accountable for assigned deliverables on key capital projects
- Suggest design modifications to address risks and design in quality and safety.
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Act as a liaison between Engineering and Quality Assurance during project planning and closeout
- Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
- Ensure safety during commissioning validation maintenance and manufacturing activities
- Related Activities:
- Participate or lead when required multidisciplinary site teams e.g. Cross Functional Team Root Cause Analysis lead.
- Support Lean Transformation and Excellence in Operations process improvement by leading supporting and documenting improvement opportunities to reduce cost improve safety/quality or improve speed.
- Provide ad hoc technical support and guidance for manufacturing and maintenance
- Provide coaching and guidance to project teams and engineers using riskbased approaches
- Defend the equipmentspecific calibration maintenance & validation as required during regulatory inspections
- Participate in internal audits and assess in conjunction with quality assurance
- Assist in developing and maintaining business metric performance
Top Must Have Skill Sets:
- Fundamental client Leadership and Values preferable to see former client workers
- Good Communication / Safety / Quality Focused
- Fundamental Technical Knowledge
Day to Day Responsibilities:
- Support Epogen Commercial manufacturing equipment
- Model leadership behaviors and positive values to create a positive working environment.
- Be individually accountable for the consistent equipment performance
- Be accountable for assigned deliverables on key capital projects
- Suggest design modifications to address risks and design in quality and safety.
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Act as a liaison between Engineering and Quality Assurance during project planning and closeout
- Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
- Ensure safety during commissioning validation maintenance and manufacturing activities
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:
- Bachelors degree in engineering or another sciencerelated field
- 7 years of relevant work experience with 5 years experience in operations/manufacturing environment
- Direct experience with regulated environments (FDA OSHA EPA etc.
- Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes clean utilities facilities instruments and equipment
- Experience implementing riskbased verification on major GMP process equipment / automation projects including validation protocol development and
- Experience with combination product / medical device quality systems verification
- Process equipment knowledge basic principles of cell culture fermentation purification filling
- Process automation knowledge fundamental understanding of automation infrastructure
- Knowledge of Delta V Rockwell and Plant Information Systems is a plus
- Strong communication and technical writing skills
- Strengths in facilitation and collaboration / networking
- Experience in developing SOPs and delivering training
- Individual must be a team player prepared to work in and embrace a teambased culture that relies on collaboration for effective decisionmaking
- Basic understanding of process improvement methodologies to mature and improve business performance (examples: PDCA LEAN Six Sigma etc.
Red Flags:
- Safety not recognized as top priority
- Poor communication
- Has issues under stressful situations
- Blames other for negative situations
Interview Process:
One phone screen/onsite interview.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Hourly
Key Skills
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