Description:

FULLY ONSITE AT USTO

This engineering 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 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 Engineer role will provide direct engineering technical support as follows:

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

• Be individually accountable for the consistent equipment performance

• Be accountable for assigned deliverables on key capital projects

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

• 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

• 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

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

• Experience with combination product / medical device quality systems verification

• Process equipment knowledge - basic principles of cell culture fermentation purification filling

• Process automation knowledge - fundamental understanding of automation infrastructure

• Knowledge of Delta V Rockwell and Plant Information Systems is a plus

• 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

• Basic understanding of process improvement methodologies to mature and improve business performance examples: PDCA LEAN Six Sigma etc.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.