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Actalent Process Engineer in Thousand Oaks, California

Description:

Onsite Thousand Oaks - 3 days a week. Schedule is typically 8am - 5pm some flexibility with schedule may be expected to work OT 10 of the time during peak season Q4 Ideal candidate: Biotech and pharma GMP environment. Combination products English written and verbal skills MS Office SmartSheets project scheduling software Project management skills in a supporting role. PMP certification is desired Lets do this. Lets change the world. In this dynamic role you will organize Technology Transfer activities for Final Drug Product manufacturing. Supporting and creating project schedules dashboards and leading team meetings to progress the project final objectives. This will include working across a global and cross functional team consisting of manufacturing device and packaging design for combination product capital projects physical test methods quality and regulatory team members. To effectively serve patients we build effective Technology Transfer plan and schedule for our combination products that enhance end to end controls with robust methods with data flow to our digital infrastructure in a GMP setting. Responsibilities of this position may include: Supporting Tech Transfer project scheduling activities for FDP Support New Product Introduction to Amgen manufacturing site Owning documentation such as Project Plan supporting engineering with PTD Process Transfer Document Protocols and reports Supporting engineers with M-a-B Make-a-Batch activities to make sure the sending/receiving sites expectation are met Developing tracking and providing project dashboard updates Providing good communication plan to cross functional team and Process Engineer management Ability to apply project management and engineering science to production Strong teamwork excellent interpersonal and communication skills Basic Qualifications: Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience Experience in a Combination Product field with a focus on project management and/or manufacturing. Experience and knowledge of interdependencies of complex projects with new product introductions with new equipment/processes. Knowledge of Combination Product design controls and Regulatory requirements on a global scale Understanding of Amgen commercialization framework. Program and Project Management skills experience with MS Project SmartSheets and other project scheduling software is desired PMP certification is desired. Proactive risk assessment management and mitigation. Ability to lead and succeed in ambiguous environment. Strong project management skills.

Skills:

Combination Products, smartsheet, pmp, gmp, gmp environment, biotech, biotechnology, pharmaceutical

Top Skills Details:

Combination Products,smartsheet,pmp,gmp,gmp environment,biotech,biotechnology,pharmaceutical

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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