Engineer - Drug Product - Thousand Oaks, CA | Biospace
Get Our FREE Industry eNewsletter

Engineer - Drug Product

Amgen

Apply
Location:
Thousand Oaks, CA
Posted Date:
6/28/2017
Position Type:
Full time
Job Code:
R-39552
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

As a member of the ATO Development Supply Chain - Engineering and Facility Reliability organization, this position will primarily serve as plant engineer support for the Drug Product process equipment (formulation, aseptic filling, cleaning/sterilization, & inspection) in a GMP manufacturing facility.

Responsibilities include:

Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems.  This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment

Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order

Monitor systems to identify performance risks and implement risk reduction strategies

Providing troubleshooting support to reduce production downtime.  This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action

Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs

Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations

Requirements

Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of Engineering experience

OR

Associate's degree and 6 years of Engineering experience

OR

High school diploma / GED and 8 years of Engineering experience

Preferred Qualifications

Bachelor's degree in Chemical Engineering or Bioengineering

6+ years' of relevant work experience with 5+ years' experience in operations/manufacturing environment

Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation

Direct knowledge of design and troubleshooting with Drug Product equipment/operations such as vials washers, filling machines, Isolators, capping machines, autoclaves, depyrogenation ovens, etc.)

Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)

Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects

Understanding of the execution process of capital projects in a GMP pharmaceutical facility including procurement, construction, startup, and validation

Understanding of safety requirements working in a Drug Product plant

Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration

Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making

Strong leadership, technical writing, and communication/presentation skills

Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage

Up to 10% domestic travel

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.