Search Jobs
Senior Engineer
Job Description
*Depending on experience
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.
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
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
Preferred 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.
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.)
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Thousand Oaks, CA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.