Manager Engineering - Thousand Oaks, CA | Biospace
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Manager Engineering

Amgen

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Location:
Thousand Oaks, CA
Posted Date:
4/27/2017
Position Type:
Full time
Job Code:
R-31890
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Amgen is looking for a Manager Engineering to join our team that will lead a small group of automation engineers and/or technical professionals delivering automation services at the Thousand Oaks B7 Epogen® (EPO) manufacturing facility.  As a member of the Thousand Oaks Building 7 Manufacturing team, the Manager Engineering will support complex and challenging system automation initiatives and will be primarily responsible for supporting manufacturing operations in Amgen's Building 7 facility through effective troubleshooting and ensuring automated equipment uptime and reliability.

Position Responsibilities:

Ensure safety of all personnel during plant operations across multiple shifts covering 24/7 plant operations

Ensure that all staff are adequately trained and comply with Good Manufacturing Practices (GMP) standards and procedures

Responsible for staff selection, training, oversight, coaching, performance evaluations and development

Perform extensive programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies

Advanced automation engineering in the design, specification, construction, startup and validation of process equipment and systems for capital projects of significant scope and complexity

Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA)

Lead and support capital projects, development of detailed specification, engineering documents and standard operating procedures

Own and administer process control automation in a GMP regulated manufacturing setting

Process change control requests per established SOP and processes

Lead technical root cause analysis, incident investigations and troubleshooting on process control issues related to electrical, instrumentation and control systems

Design and test new and currently installed automation based process equipment

Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs

Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles

Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations

Work schedule flexibility to support 24/7 operations and occasional after hours engineering coverage

Requirements

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Manufacturing Engineering experience

OR

Bachelor's degree and 5 years of Manufacturing Engineering experience

OR

Associate's degree and 10 years of Manufacturing Engineering experience

OR

High school diploma / GED and 12 years of Manufacturing Engineering experience

AND

Previous managerial experience directly managing people and/or  experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or life science engineering

Excellent control systems automation background focused specifically in design, installation, programming and validation of automated processes

3+ years combined experience with the following product platforms: 1)Emerson Delta-V DCS systems version 11 or above 2) Rockwell Automation Factory Talk & ControlLogix PLC, 3) Mitsubishi PLC, 4) ABB Robotics

1+ years' experience leading a team

Create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR, among other engineering and validation documentation

Knowledge of ASTM 2500, S88 and S95 techniques

Batch processing experience

Leadership, technical writing and communication/presentation skills

Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11 and GAMP

Experience in developing automation strategies for new product introduction and new technology deployment

Experience in process control engineering and troubleshooting with unit operations such as media, harvest, bioreactors and ultrafiltration/diafiltration

Experience with CIP's, COP's, Glass washers and Autoclaves

Knowledge of building automation systems, electronic batch records, PLC, OPC, Foundation Fieldbus, Profibus and DeviceNet technologies, as well as HVAC, purified water systems (RO, WFI)

Knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities and equipment

Experience in change control, nonconformance, corrective and preventative actions and validation practices

Organized and able to multi-task in project environments

Skilled in communication, facilitation and collaboration

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

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.