Engineer Senior, Biotech Facilities & Processing Equipment Project Engineering JP

Position: Engineer Senior, Biotech Facilities & Processing Equipment Project Engineering - (JP14802)
Location: Newbury Park

Job Title: Engineer Senior, Biotech Facilities & Processing Equipment Project Engineering - (JP14802)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Facilities & Engineering Drug Product Supply
Duration: 1+ year(s) (with likely extensions and/or conversion to permanent)
Posting Date: 12/03/25
Pay Rate: $45 - $50/hour W2
Notes: Only qualifi
0065d candidates need apply. Onsite 8-5. Must have CA DL and US Passport (for business travel)

3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The position works in partnership with the maintenance, process development, project management, engineering technical authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream. Responsibilities include working closely with Quality Assurance (QA) for GMP and Safety for safety compliance. The engineer will support the projects in defining strategies for systems verification and will work with the process development / validation team to develop and document appropriate practices.

This position supports manufacturing activities associated with cGMP equipment and facilities at our client facilities in Thousand Oaks (ATO).

Why is the Position Open?
Supplement workload

Top Must Have

Skills:

• 8-10 YOE
• Engineering or construction experience in the pharmaceutical/biotechnology/regulated manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support, Reliability, asset management)
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
• Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Reliability Engineering, Six Sigma, and fundamental understanding of statistics, etc.)

Day to Day Responsibilities:
The Engineer/Project Manager role will provide direct engineering technical and project support as follows:

• Be individually accountable for the deliverables on projects.
• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Develop and present project charters/strategies to leadership.
• Developing accurate estimates & schedules, with cost and schedule risk analysis, cash flow analysis and data for benchmarking.
• Leads team effectiveness by identifying and efficiently resolving issues, facilitating and documenting decisions, and tracking action items, following appropriate escalation process.
• 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).
• Identify risks (business, quality, and safety) and develop mitigation countermeasures that are implemented.
• Partnering with commissioning lead to 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 (risk-based approach).
• Recommend, evaluate, and manage performance of contract resources.
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Act as a liaison between cross-functional teams 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
• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.

• Related
  
  Activities:

• Participate or lead,…