Job Description
- CANDIDATE MUST HAVE 3+ YEARS OF RECENT PHARMA EXPERIENCE
- CANDIDATE MUST HAVE DRUG SUBSTANCE EXPERIENCE
- BACHELORS DEGREE IN ENGINEERING - CHEMICAL/ BIO/ BIOCHEM
- CANDIDATE WILL BE WORKING ON SITE
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at client Thousand Oaks (ATO). The engineer will lead activities in alignment with client Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. 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. The engineer must work closely with Quality Assurance (QA) for GMP compliance. In addition, the engineer will support periodic review of manufacturing systems to ensure that they remain in a validated state. 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.
• Assist in development and review of User Requirements Specifications (URS).
• 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 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.
• Conduct and document periodic equipment validation reviews
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 on the CQP process and risk-based approaches to commissioning and verification
• Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
• Participate in internal audits and assess in conjunction with QA.
• Assist in developing and maintaining metrics
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
manufacturing experience
Preferred Qualifications / Skills / Experience
• Bachelor's degree in engineering
• 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.
o 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.)