Engineer Senior, Biopharma Manufacturing Process Equipment (JP13063)

Job Title: Engineer Senior, Biopharma Manufacturing Process Equipment (JP13063)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate : Market Rate DOE, with benefits
Posting Date: 10/06/2024.

3 Key Consulting is hiring! We are recruiting an Engineer Senior for a consulting engagement with our direct client, a leading global biotechnology company.

REQUIRED PRE-SCREENING QUESTIONS:

• Have you worked in a clean environment before?
• What do you consider as a continuous improvement? Can you provide an example where you improved a process and or equipment reliability?
• Can you describe a situation where you had to troubleshoot an equipment failure? How did you go about resolving it? What was the outcome?
• Are you familiar with clean and sanitized systems such as clean in place systems (CIP), clean out of place systems (COP), glasswashers, and autoclaves?
• Are you familiar with stainless steel bioreactors? Tanks? And their operation? Can you provide the sizes of the systems you worked with? (example 2,000 L bioreactor, 100 L – 2,000L stainless steel tanks)
• Why is it important to maintain the sterile boundary of a bioreactor?

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 client’s 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 (risk-based 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, execution, 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 risk-based approaches
• Defend the equipment-specific 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 Master’s degree & 3 years of engineering and/or manufacturing experience OR Bachelor’s degree & 5 years of engineering and/or manufacturing experience OR associate’s degree & 10 years of engineering and/or manufacturing experience
Preferred Qualifications:

• Bachelor's degree in engineering or another science-related 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 risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
• 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 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.)

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 [email protected] . Ifyou 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 You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

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