Description:

Onsite - Thousand Oaks CA

Must be local- not interested in seeing job seekers who will need to relocate

Must be available for potential on call for Overtime looking at potentially 10-12 hours a month.

This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks ATO. The engineer will lead activities in alignment with Amgens Commissioning and Qualification Process CQP to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance project management the engineering technical lead and manufacturing to develop and oversee the implementation operation and reliability of equipment. The engineer will work closely with Quality Assurance QA to ensure GMP compliance and address potential gaps. In addition the engineer will evaluate equipment maintenance plans support periodic review of manufacturing systems and investigate root causes of equipment issues. 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.

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

Demonstrated strong communication and technical writing skills

Strengths in facilitation and collaboration / networking with cross-functional groups

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.

Problem solving skills using scientific and engineering methods and investigative skills for root cause analysis.

Availability to support outside regular hours as needed

Demonstrate skills in the following areas:

Problem solving and applied engineering.

Basic technical presentations.

Personal organization.

Adapting to and managing change.

Project and document management systems CDOCS E-Builder PCS BMS and QEMS.

Validated GMP management systems Maximo CMMS Trackwise

Project management and cost development

Conflict Resolution

Leadership and team building

Skills:

troubleshooting, cmms, maximo, trackwise, gmp, fda, osha, epa regulations, sop

Top Skills Details:

troubleshooting,cmms,maximo,trackwise,gmp,fda,osha,epa regulations,sop

Experience Level:

Intermediate Level

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 ( actalentaccommodation@actalentservices.com) for other accommodation options.