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Manager Engineering - United States  

Company managed [?] Still accepting applications

Posted on : 01 May 2017

Project 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

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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.