Thousand Oaks, CA, USA
Category: Maintenance Job ID: R-74232 Location: Thousand Oaks, CA, US 91360 Posted Date: 4/9/2019
Amgen Thousand Oaks is seeking a Senior Instrument Technician to report to the Maintenance Manager. The Senior Instrumentation Technician is responsible for performing calibration, repair, installation, troubleshooting and documentation of instruments used on process control systems and building systems in production plants, utility plants and facilities suited and designed for material manufacturing. All work must be completed in a safe and timely manner in accordance to Hazard Risk Assessments (HRA) and Job Hazard Assessments (JHA).All work will be performed according to planning and predefined schedules with minimal impact to production while complying with Good Manufacturing Practices (GMPs), standard operating procedures (SOP) and Amgen policies and regulations.
Perform calibrations of metrology related equipment
Perform instrument calibrations for process, utility and analytical equipment and systems
Troubleshoot and repair site instrumentation and control system issues
Ensure work is completed in a safe and compliant manner in accordance with applicable procedures
Ensure that calibration and repair activities are documented in an accurate and compliant manner
Execute according to planning and predefined schedules with minimal impact to production while complying with GMP, SOP, CFR and Amgen regulations
Knowledge of pneumatic, mechanical, and electronic instrumentation fundamentals, including process control loops, loop checks, loop tuning and troubleshooting computer based control systems (PLC, BMS, DCS, and various HMI)
Review and provide feedback on calibration and maintenance reports, forms, and records
Revise and review calibration, maintenance or other related procedures
Provide regulatory and partner audit support
Interpret electrical schematics, I/O wiring and panel drawings, utility, process system/equipment, plumbing, ductwork, and HVAC P&ID's
Interact with peers and clients in manufacturing, maintenance, utility plants, analytical labs and contracted services
Perform general labor duties and may work in a variety of locations
Participate in on-call rotations for after-hours facility and manufacturing support and work outside of established shift hours upon short notice
Associate’s degree and 4 years of instrumentation/calibration experience
High school diploma / GED and 6 years of instrumentation/calibration experience
Associate’s degree in metrology, instrumentation, electronics, or related technical discipline
Experience performing maintenance and troubleshooting on electrical systems up to 480V
2 years in an FDA (GMP) or similar regulated environment
Experience executing and documenting instrumentation work orders in Maximo or similar computerized maintenance management system
Strong leadership, technical writing and communication/presentation skills
Advanced understanding of process control loops, loop checks, and loop tuning of process control systems
Experience with Rosemount instrumentation, Foundation Fieldbus communications and Delta V process control system
A high mathematical understanding, excellent reading skills along with intermediate computer and typing skills
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
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.
Thousand Oaks, CA, USA
Category: Quality Job ID: R-81609 Location: Thousand Oaks, CA, US 91360 Additional Location: Posted Date: 8/15/2019
The Associate, Quality Control will support the QC Microbiology lab by performing Environmental, Gowning and Utility Monitoring within the manufacturing areas at Amgen, Thousand Oaks.
Candidates interested in this position must be willing to work a Monday-Friday, 5am-2pm shift with occasional weekend and holiday work.
Key Responsibilities Include:
• Collecting surface, air, gas and gowning samples using aseptic technique and in accordance with Amgen Analytical Methods and Standard Operating Procedures
• Aseptic gowning
• Operating and maintaining specialized equipment
• Data entry and approval using Laboratory Information Management Systems
• Quality systems support, which may include Deviation ownership and controlled document revisions
• Implementation of laboratory/process improvements to ensure a productive and efficient work environment
Associate’s degree and 4 years of Quality Control or Manufacturing experience
High school diploma / GED and 6 years of Quality Control or Manufacturing experience
• Experience and training in aseptic technique/aseptic gowning
• Basic knowledge of the principles of Microbiology
• Laboratory Information Management Systems experience
• Technical and investigation writing skills
• Demonstrated problem-solving capabilities, leadership skills and ability to independently implement process improvements
Thousand Oaks, CA, USA
Category: Manufacturing Job ID: R-81973 Location: Thousand Oaks, CA, US 91360 Additional Location: Posted Date: 8/16/2019
The Associate of Manufacturing will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and launch activities. Under general supervision, employee will perform operations in the Manufacturing area, specifically B23 Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). This Associate is responsible for hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures.
Perform and monitor critical processes
Execute routine validation protocols
Comply with GMP's
Regularly draft and revise “routine” documents (e.g. MPs, SOP’s, and technical reports)
Initiate Quality incidents
Identify and recommend improvements related to routine functions and implement after approval
Recognize and accurately report problems
Direct operators on critical processes
Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)
May train staff to perform hands-on tasks
May act as safety representative
May participate on cross-functional teams and represent the
Associate’s degree and 4 years of Manufacturing /Operations experience
High school diploma / GED and 6 years of Manufacturing /Operations experience
Bachelor’s Degree in Biology and/or Life Sciences
Able to work in teams to complete operational tasks
Ability to take direction well, follow documents and policies at all times
Ability to take initiative
Create a positive work environment through interactions with team members
Able to lift up to 50lbs and work on your feet for long durations
Thousand Oaks, CA, USA
Category: Manufacturing Job ID: R-81967 Location: Thousand Oaks, CA, US 91360 Additional Location: Posted Date: 8/16/2019
The successful candidate will direct a team of manufacturing associates responsible for manufacture of GMP DSI/DS in both stainless and single-use equipment. The manager will foster a safe and compliant production environment through structured on-the-floor presence. The incumbent will also be an active participant and role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor. The successful candidate must demonstrate strong leadership skills and technical understanding of production operations.
Staff selection, training, oversight, performance evaluations, and development
Daily schedule alignment
Partner with QA and other groups to ensure deviations are initiated and closed within target timelines
Utilize appropriate systems to perform job duties (SAP/MES, QMTS, LIMS etc.).
Interact with business partners and internal/external audit teams and regulatory authorities.
Identify and implement process and safety improvements.
Work with business partners to support scheduling of maintenance tasks, engineering support, and quality investigations.
Effectively elevate critical and impactful events to senior management.
Make real-time processing decisions to support compliant and safe production.
Ensure batch record review is completed accurately to support disposition timelines
Flexible work schedule, including night/graveyard shift and weekend/holiday work as decided by business needs.
Master’s degree and 2 years of manufacturing or operations experience
Bachelor’s degree and 4 years of manufacturing or operations experience
Associate’s degree and 10 years of manufacturing or operations experience
High school diploma / GED and 12 years manufacturing or operations experience
5+ years of related manufacturing experience.
3+ years of experience as a production area Lead, Specialist or Manager
Strong technical understanding of Cell Culture and Purification processes and equipment
Demonstrated presentation and leadership skills
Proven experience with continuous improvement methodologies
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
Strong quality system and GMP knowledge
Strong troubleshooting skills with laboratory and process equipment
Energetic and technically-minded, with strong interpersonal and organizational skills
Demonstrated ability to learn new systems and applications, and various new technologies
Degree in Life Science, Chemistry or Engineering