Engineer Senior - Technical Support GMP Manufacturing JP12779
Engineer Senior - Technical Support GMP Manufacturing JP12779
Posted on :
10-04-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 45 - 50
Vacancy
1 Vacancy
Posted on :
10-04-2025
Job Description
Job Title: Engineer Senior Technical Support GMP Manufacturing (JP12779
Location: Thousand Oaks CA. 91320
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1 years (with possible extensions)
Rate: $45 $50/Hr with benefits
Posting Date: 6/24/2024.
Notes: Only qualified candidates need apply. Fully onsite. Standard business hours
3 Key Consulting is hiring! We are recruiting an Engineer Senior for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
*** Looking for hands on *STRONG* engineer experience with proper training/ background in technical side/ mathematics. NOT LOOKING for quality lab/ bench top/ science work. The job seeker needs to be practical with troubleshooting and be able to hold a technical conversation. Transferrable Industry backgrounds: Drug substance/ pharma / chemical/ oil refinery/ mechanical
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at our clients Thousand Oaks CA. facility. The senior 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 Senior Engineer role will provide direct engineering technical support as follows:
Related Activities:
Top Must Have Skill Sets:
Basic Qualifications:
Preferred Qualifications:
Why is the Position Open
Supplement additional workload on team
Red Flags:
Interview Process:
WebEx
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: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1 years (with possible extensions)
Rate: $45 $50/Hr with benefits
Posting Date: 6/24/2024.
Notes: Only qualified candidates need apply. Fully onsite. Standard business hours
3 Key Consulting is hiring! We are recruiting an Engineer Senior for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
*** Looking for hands on *STRONG* engineer experience with proper training/ background in technical side/ mathematics. NOT LOOKING for quality lab/ bench top/ science work. The job seeker needs to be practical with troubleshooting and be able to hold a technical conversation. Transferrable Industry backgrounds: Drug substance/ pharma / chemical/ oil refinery/ mechanical
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at our clients Thousand Oaks CA. facility. The senior 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 Senior Engineer role will provide direct engineering technical support as follows:
- Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.
- Be individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverables
- Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
- Suggest design modifications to address risks and design in quality and safety.
- Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (riskbased approach).
- Oversee development of validation protocols in line with CQP Automation Systems Delivery SOPs and cGMP standards.
- Recommend evaluate and manage performance of contract resources
- 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 work executed with safety compliant practices and documented in accordance with cGMP good documentation
- Review and approve the commissioning reports maintenance practices and parts and drive productivity improvement
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:
- Looking for hands on *STRONG* engineer experience with proper training/ background in technical side/ mathematics. (NOT LOOKING for quality lab/ bench top/ science work).
- The job seeker needs to be practical with troubleshooting and be able to hold a technical conversation. Transferrable Industry backgrounds: Drug substance/ pharma / chemical/ oil refinery/ mechanical
- Troubleshooting GMP Manufacturing process equipment.
- Statistical Process Control (SPC) Quality Management Systems (QMS) Change Control Project Management Lean Six Sigma SOP/Batch Record Development cGMP Regulatory Compliance Process Development Process Validation.
- Bioprocess development and scaleup (cell culture harvest (isolation) and product assays).
- Process characterization
- Technical writing.
- Tech transfer to cGMP manufacturing and training personnel
Basic Qualifications:
- Doctorate degree OR Masters degree & 3 years of engineering and/or manufacturing experience OR Bachelors degree & 5 years of engineering and/or manufacturing experience OR associates degree & 10 years of engineering and/or manufacturing experience OR High school diploma / GED & 12 years of engineering and/or manufacturing 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
- Understanding and awareness of industry/regulatory trends for verification/validation
- Experience with combination product / medical device quality systems verification
- Strong process equipment knowledge cell culture fermentation purification filling and packaging
- Strong process automation knowledge understanding of automation infrastructure current technologies and automation project / verification.
- Knowledge of Delta V Rockwell and Plant Information Systems is a plus
- Demonstrated 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
- Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA LEAN Six Sigma and fundamental understanding of statistics etc.
Why is the Position Open
Supplement additional workload on team
Red Flags:
- Resumes should not be brief and have proven documented experience
- Poor Communication
- Poor Leadership
- Poor Teamwork
Interview Process:
WebEx
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
Required Experience:
Director
Employment Type
Full Time
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