Equipment Specialist

4 weeks ago

Thousand Oaks, California, United States ACL Digital Full time

Job Title: Senior Equipment Engineer

Location: Thousand Oaks, CA

Duration: 12+ Months

Description:

This senior equipment engineer position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing teams to develop and oversee the operation and reliability of equipment while driving safety and quality compliance.

The senior equipment engineer will provide direct engineering technical support as follows:


• Demonstrating leadership behaviors and positive values to create a positive working environment.


• Being individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverables.


• Assisting in the identification of critical quality parameters and process attributes for new equipment or facility modifications.


• Suggesting design modifications to address risks and design in quality and safety.


• Developing 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).


• Overseeing the development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.


• Recommending, evaluating, and managing the performance of contract resources.


• Providing oversight for verification deliverables developed by outsourced/contract verification staff.


• Acting as a liaison between engineering and quality assurance during project planning, execution, and closeout.


• Ensuring that work is executed with safety-compliant practices and documented in accordance with cGMP good documentation.


• Reviewing and approving the commissioning reports, maintenance practices, and parts, and driving productivity improvement.

Related Activities:


• Participating or leading, when required, multidisciplinary site teams, e.g. cross-functional team, root cause analysis lead.


• Supporting Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.


• Providing ad hoc technical support and guidance for manufacturing and maintenance.


• Providing coaching and guidance to project teams and engineers using risk-based approaches.


• Defending the equipment-specific calibration, maintenance, & validation as required during regulatory inspections.


• Participating in internal audits and assessing in conjunction with quality assurance.


• Assisting 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.)

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