In this position, you will be responsible for providing day to day automation engineering support for on-going GMP Operations. You will be part of the Bulk Drug Substance (BDS) Engineering group which will require a good working knowledge of the basic BDS unit operations: Bioreactors, Chromatography skids, Ultrafiltration skids, CIP skids, Media and Buffer Preparations as well as SIP processes. You will be an expert in at least one of the following control systems: Delta V, Allen-Bradley PLCs (and Rockwell Software packages), Modicon PLCs (and Wonderware HMI and Batch software packages), Siemens (Landis&Gyr) Building Automation Systems, iFIX SCADA. You will be well versed in all aspects of control system life cycle management in a regulated environment (best if that is FDA regulated, but not required). You will be familiar with all the requirements of making changes, documenting them, and releasing back to production. Familiarity with common change control management systems like TrackWise is a plus. Since Thousand Oaks is a 7/24 operation, you will be required to give off-hour support on an on-call basis. In addition, since Thousand Oaks is an end to end facility, some experience with Filling equipment, Lyophilizers, Packaging equipment, common utility systems like WFI, Clean Steam, RO Water, would be an added benefit. Other welcome, but not required skills would be familiarity with Siemens PCS7 (and WinCC HMI package), OSI PI Historian, participation in small and large capital project execution teams.
Essential Duties & Responsibilities
1) Ability to work with multiple customers: manufacturing, maintenance, project engineering, QA, Validation, etc. Understand the needs of each, prioritize solutions to meet these needs to garner the biggest impact for the time and dollars invested.
2) Investigate, analyze and resolve customer service problems in a high pressure environment. Be able to quickly implement solutions that get production back up and running as well as recommending long term design solutions that address root causes.
3) Administer all aspects of the control system life cycle in a regulated environment. Keep all software and documentation up to date and in a state of complete compliance at all times.
4) Subject Matter Expert (SME) expected to lead and mentor other process control engineers and/or technicians on the operation and maintenance of the various control systems in the facility.
5) With minimal guidance, schedules and leads a team through the planning and execution of a smaller project or a defined piece of a larger project. This includes constructing detailed, accurate project schedules and cost estimates, preparing business case justifications, interfacing with cross-functional development groups and technical support groups.
6) Ability to manage routine small projects with complex features without assistance.
7) May also be required to act as lead for the BDS Engineering group
1) Experience working in an automation support role in a 7/24 operation.
2) Knowledge of Bulk Drug Substance unit operations: Bioreactors, Chromatography skids, Ultrafiltration skids, CIP skids, Media and Buffer Preparations as well as SIP processes. Fill and Finish experience is a plus.
3) Knowledge of control system life cycle management in a regulated environment (best if that is in a cGMP, FDA regulated environment)
4) Experience leading and mentoring less experienced engineers. Supervisory experience is a plus.
5) Some experience running projects large or small (experience with creating schedules and cost estimates, as well as common project management tools like MS Project)
6) Ability to communicate through all levels of the organization, able to suggest constructive solutions even if going against popular opinion or higher ranking individuals. Excellent verbal and written communication skills.
- Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
- Be Positive
- Be Accountable
- Be Results Oriented
Be An Excellent Manager of Self and Others
Education and/or Experience
A minimum of a Bachelor’s degree in engineering with at least 5-8 years of related automation/controls experience in a GMP pharmaceutical environment is required.
Experience with at least one of the following (more is a plus) control systems: Delta V, Allen Bradley, Intellution/iFix, Siemens BAS, Siemens PCS7, WinnCC, Modicon PLC, Wonderware (HMI and Batch), OSI-PI Historian.
- May occasionally work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
• May occasionally be working in a loud area that requires hearing protection and other protective equipment to be worn.
• May work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
• Will be required to participate in the Engineering department’s after hour on-call support
• May be required to work or be assigned to a different shift as needed
• Must be able to work more than 8 hours a day or 40 hours a workweek as required
• May occasionally require shift, weekend and holiday work.
• Will have interaction with other people.
• Pace may be fast and job completion demands may be high.
• May be required to travel for business reasons, e.g. training and meetings.
• The overall physical exertion of this position is sedentary work. Sedentary work involves lifting no more than 10 pounds at a time and occasionally lifting or carrying articles like files, ledgers, and small tools. Although a sedentary job is defined as one, which involves sitting, a certain amount of walking and standing is often necessary in carrying out job duties.
• May be required to stand and walk frequently to access other areas in the facility.
• Will be required to use repetitive motion frequently of hand, fingers, and wrist for the purpose of typing and data entry.
• Will be required to grip and grasp frequently when using computer mouse.
Location/Region: Thousand Oaks, CA