- 06-Mar-2017 to 31-May-2017 (PST)
- Tustin, CA, USA
- Full Time
Avid Bioservices is an established Contract Development and Manufacturing Organization (CDMO) based in Orange County, CA. We are a subsidiary of Peregrine Pharmaceuticals which is on the list of Deloitte & Touche's 500 fastest growing North American technology companies. Avid invites you to bring us your excellent cGMP facilities expertise and proven abilities in the biotech industry.
We are a government contractor. At this time, we cannot provide sponsorship nor relocation.
- Controls Engineer maintains control systems for manufacturing processes and utilities in a maximum state of reliability. Identifies problems and potential issues with control systems and automated processes. Participate in plans, installs, start-up, commissioning, document upgrades/installs of PLC, DDC, DCS, SCADA based control systems for Biopharmaceutical process equipment and Plant Utilities.
- Serve as a lead in all technical requirements for the facility equipment especially the bioreactors (100L 1000L stainless steel and disposable STR/SUB) in order to ensure that the technical operations are aligned with maximizing production effectiveness and optimizing performance to lower overall operating costs.
- Partner with operations, quality assurance and any vendors and suppliers in order to create positive relationships to strengthen this proactive role in the facility.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Maintain existing control systems in reliable condition, propose improvements, and train/support manufacturing and maintenance personnel.
- Perform predictive, preventative and corrective maintenance efforts required to ensure efficient, reliable and uninterrupted plant operations.
- Also supports the specification, acquisition and installation of equipment especially bioreactors (100L 1000L stainless steel and disposable STR/SUB).
- Troubleshoot different controller software and hardware components.
- Conduct timely/competent root cause analyses. Recommend/implement innovative, efficient and effective corrective actions resulting in stable and capable processes.
- Track and evaluate critical process data to recommend continuous process improvement.
- Participate in equipment troubleshooting in order to correct/maintain quality production. Recommend and implement measures to improve production methods, equipment performance, and quality of product.
- Develop and maintain electrical and P&ID drawings.
- Support validation and manufacturing projects.
- Maintain current knowledge of regulatory and industry standards.
- Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
- Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
- Strict adherence to procedures and practices according to FDA regulations.
- Strong emphasis on documentation according to FDA standards.
- Adhere to departmental corporate safety policies.
Education, Experience and Skills Desired:
- Degree in Electrical Engineering, Automation Technology or closely related technical discipline or comprehensive work experience.
- Minimum of 3 years related hands on experience maintaining automated manufacturing systems and equipment, ideally in an FDA / cGMP regulated environment.
- Knowledge with industrial networking (DeviceNet, Profibus, Ethernet) and SCADA systems, in particular Wonderware Intouch.
- Experience with DDC, DCS, PLCs, industrial networks, drives, motor controls, sensors, automation components, control instrumentation, proportional valves, servo controls, SCADA, HMI troubleshooting is strongly preferred.
- Knowledge and familiarity with Wonderware, RSView, panel builder, RS logix 500, Delta system, DeltaV and Rees scientific strongly preferred.
- Knowledge with various types of process instrumentation (Calibrated assets).
- Familiar with Air Handler HVAC (Heating, Ventilation & Air-Conditioning) systems.
- Familiar with PID controls and cascading controls.
- Understanding of good programming standards and practices.
- Proven ability to independently learn and troubleshoot systems and devices from manuals, P&IDs, Electrical and Electronic schematics, catalogs and equipment cut-sheets.
- Proven ability in the use of measurement and test equipment including volt, current, impedance, rpm, conductivity, as well as signal analyzer, network tester, mA source, etc.
- Familiar with common codes and standards including NEC, IEEE, UL, NEMA, and OSHA.
- Familiar with electrical circuits including 3 phase 480Vac, 120Vac, and 24Vdc power distribution.
- Familiar with Virtual Servers and Windows Server.
- Experience in using hand tools and all required PPE
- Good Technical writing skills.
- Must have strong attention to detail.
- Self-starter with strong work ethic.
- Can prioritize and manage multiple tasks to meet targeted deadlines.
- Strong interpersonal skills to interact daily with personnel at all levels in a team environment.
- Knowledge and proficient with basic MS Office (Outlook, Word and Excel).
EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.
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