Engineer Facilities Equipment and Analytical support JP11900
Engineer Facilities Equipment and Analytical support JP11900
Posted on :
11-04-2025
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1 Vacancy
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Hourly Salary
$ 38 - 42
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
Job Title: Engineer Facilities Equipment and Analytical support (JP11900
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: 10/18/2023
Notes: Only qualified candidates need apply. Fully onsite.
3 Key Consulting is recruiting an Engineer Facilities Equipment and Analytical Support 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 clients site in Thousand Oaks. The engineer will lead activities in alignment with clientss Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance project management the engineering technical lead and manufacturing to develop and oversee the implementation operation and reliability of equipment. The engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition the engineer will evaluate equipment maintenance plans support periodic review of manufacturing systems and investigate root causes of equipment issues. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.
Top Must Have Skill Sets:
Day to Day Responsibilities:
The engineer will lead activities in alignment with clients Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance project management the engineering technical lead and manufacturing to develop and oversee the implementation operation and reliability of equipment. The engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition the engineer will evaluate equipment maintenance plans support periodic review of manufacturing systems and investigate root causes of equipment issues. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization. The Engineer role will provide direct engineering technical support as follows:
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 and one virtual panel 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: 10/18/2023
Notes: Only qualified candidates need apply. Fully onsite.
3 Key Consulting is recruiting an Engineer Facilities Equipment and Analytical Support 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 clients site in Thousand Oaks. The engineer will lead activities in alignment with clientss Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance project management the engineering technical lead and manufacturing to develop and oversee the implementation operation and reliability of equipment. The engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition the engineer will evaluate equipment maintenance plans support periodic review of manufacturing systems and investigate root causes of equipment issues. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.
Top Must Have Skill Sets:
- Fundamental client Leadership and Values preferable to see former client worker
- Good Communication / Safety / Quality Focused
- Fundamental Technical Knowledge.
- Person will be working in a manufacturing environment but in this posting we are looking for an engineer with strong ANALYTICAL skills and background
Day to Day Responsibilities:
The engineer will lead activities in alignment with clients Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance project management the engineering technical lead and manufacturing to develop and oversee the implementation operation and reliability of equipment. The engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition the engineer will evaluate equipment maintenance plans support periodic review of manufacturing systems and investigate root causes of equipment issues. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization. The Engineer role will provide direct engineering technical support as follows:
- Be individually accountable for the verification deliverables on key capital projects.
- Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
- Oversee development of validation protocols in line with CQP and cGMP standards.
- Lead evaluate and manage performance of contract resources.
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Act as a liaison between Engineering Manufacturing 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.
- Review and approve the commissioning report and ensure that all validation exceptions have been adequately addressed.
- Conduct and document periodic equipment validation reviews.
- Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone 5Why etc.
- 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
- Provide coaching and guidance to project teams and engineers on the CQP process and riskbased approaches to commissioning and verification
- Defend the equipmentspecific calibration maintenance & validation as required during regulatory inspections
- Participate in internal audits and assess risks in conjunction with QA.
- Assist in developing and maintaining metrics related to equipment performance
- Provide technical expertise to develop reliability improvement plan including design requirements maintenance strategy spare part procurement.
- Lead improvement implementation plans while following safety requirements
- Assist with equipment maintenance and troubleshooting during project duration
- Introduce and implement new analytical systems to improve reliability when needed. Lead implementation plan to ensure new systems are implemented per clients requirement.
- Contact vendors as needed to understand and assess any change impact (to equip utility facility) as improvements are planned and executed.
- Develop GMP documentation following good documentation practices including validation plans and standard operating procedures.
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
- 2 years of relevant work 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
- Demonstrated strong communication and technical writing skills
- Strengths in facilitation and collaboration / networking with crossfunctional groups
- 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.
- Problem solving skills using scientific and engineering methods and investigative skills for root cause analysis.
- Availability to support outside regular hours as needed
- Demonstrate skills in the following areas:
- Problem solving and applied engineering.
- Basic technical presentations.
- Personal organization.
- Adapting to and managing change.
- Project and document management systems (CDOCS EBuilder PCS BMS and QEMS).
- Validated GMP management systems (Maximo CMMS Trackwise)
- Project management and cost development
- Conflict Resolution
- Leadership and team building
Red Flags:
- Safety not recognized as top priority
- Poor communication
- Has issues under stressful situations
- Blames other for negative situations
Interview Process:
One phone and one virtual panel 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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