Apply to Engineer Facilities & Manufacturing Operations (JP11989)

Job 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:

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.