Summary:
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Thousand Oaks (ATO). 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.
Responsibilities:
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 is 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:
Participating 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
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 OR High school diploma / GED & 12 years of engineering and/or manufacturing experience
Qualifications / Skills / Experience
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.)
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does notreplace human-based decision making inemployment decisions.