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Engineer Facilities & Manufacturing Operations (JP11989)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer Facilities & Manufacturing Operations (JP11989)
Location: Thousand Oaks, CA. 91320
Business Unit: F&E Drug Substance Supply
Employment Type: Contract
Duration: 4+ months (with possible extensions)
Rate: $36 - $41/hour W2
Posting Date: 11/13/2023
Notes: Only qualified candidates need apply. Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering and manufacturing background.
3 Key Consulting is recruiting an Engineer Facilities & Manufacturing Operations for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
This engineering position supports manufacturing activities associated with manufacturing equipment and facilities at Thousand Oaks facility. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Preferred Qualifications:
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
Interview Process:
WebEx interview with a panel of 1:-3 (potentially).
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone 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: 4+ months (with possible extensions)
Rate: $36 - $41/hour W2
Posting Date: 11/13/2023
Notes: Only qualified candidates need apply. Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering and manufacturing background.
3 Key Consulting is recruiting an Engineer Facilities & Manufacturing Operations for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
This engineering position supports manufacturing activities associated with manufacturing equipment and facilities at Thousand Oaks facility. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.
Top Must Have Skill Sets:
- Engineering and technical background (process equipment, troubleshooting, data-driven tech skills)
- Teamwork experience
- Project improvement background
Day to Day Responsibilities:
- Be individually accountable for the verification deliverables
- Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
- Assist in development and review of User Requirements Specifications (URS).
- Suggest design modifications to address risks and design in quality and safety.
- Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and standards.
- Act as a liaison between Engineering and Manufacturing during project planning, execution, 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 verification exceptions have been adequately addressed
- Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
- Related Activities:
- 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 on the CQP process and risk-based approaches to commissioning and verification
- Assist in developing and maintaining metrics
- Provide concise and clear documentation for actions taken on systems
- Oversee equipment vendors and contractors.
Basic Qualifications:
- Master’s degree OR
- Bachelor’s degree & 2 years of engineering and/or manufacturing experience OR
- Associate’s degree & 6 years of engineering and/or manufacturing experience OR
- High school diploma / GED & 8 years of engineering and/or manufacturing experience
Preferred Qualifications:
- Bachelor's degree in engineering-related field
- 5+ years of relevant work experience with 3+ 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 risk-based verification on major process equipment / automation projects, including validation protocol development and execution
- Process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
- Process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / 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 team-based culture that relies on collaboration for effective decision-making
- 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 and applied engineering.
- Basic technical report writing and presentations
- Verbal communication
- Personal Organization
- Dealing with and managing change
- Technical (Equipment Specific)
- Analytical Problem Solving
- Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS)
- Specialized equipment/process expertise
- Ability to handle multiple projects at the same time
- Schedule development, Facilitation and collaboration
- Basic project management, project completion and follow-up
- Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
- Negotiation, persuasion and facilitation Collaboration
- Project Cost development
- Conflict Resolution
- Customer service in a technical setting
- Management of contractors and vendors.
- Flexibility to work off-hours and fully on-site
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
- No work experience
- No engineering or technical experience
- No collaboration experience
Interview Process:
WebEx interview with a panel of 1:-3 (potentially).
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards,
3KC Talent Acquisition Team