Shire Senior Process Engineer in Thousand Oaks, California

Summary

Responsible for providing day to day equipment engineering support for Formulation and Filling manufacturing systems in the facility. The engineer will have a solid understanding of filling machine and all of its components such as filling, frame loader, vial transporter, capping machine as well as CIP skids, process tanks, autoclave and part washer. The incumbent will be responsible for executing and adhering to pharmaceutical change control standards and policies. The engineer is required to spend fifty percent (50%) of his/her time on the floor and will provide techniques to improve existing equipment to minimize cost and increase efficiency. Support all equipment related investigations. The position will be responsible for creating and modifying system specifications and standard operating procedures for the systems supported. Participate in a rotating after-hours process engineering support function. Support manufacturing equipment life cycle.

Essential Duties & Responsibilities

  • Ability to prioritize multiple tasks from multiple customers.

  • Subject Matter Expert (SME) expected to lead and mentor other process control engineers and/or technicians as directed regarding formulation and Filling systems.

  • Be on the floor to study and recommend techniques to improve existing equipment to minimize production down time. Provide suggestions on how to improve an existing equipment if needed.

  • Determined basic causes and develop recommendations for corrective action, and follow-up to ensure completion of corrective action.

  • Perform troubleshooting on plant equipment and systems.

  • Investigate and analyze customer service problems and design improvement suggestions. Recommend design improvements through adaptations and modifications of standard technical principles.

  • Ability to manage routine small projects without assistance.

  • Participate off hours/weekend on call support for formulation and fill.

  • May perform other duties as assigned.

Qualifications

  • Solid experience with fill machine, Isolator, Stopper loader, tray loader, lyophilizers, process tanks and CIP skids

  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

  • Must be proficient with standard office software, such as Word, Excel and PowerPoint.

  • Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self-service applications.

  • Must have the ability to navigate electronic mail systems and intranet for communication purposes.

  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.

  • Experience in pharmaceutical, biotechnology or related field is preferred.

  • Knowledge of basic pharmaceutical production equipment including but not limited to: fill line, autoclaves, process tanks, and CIP/SIP systems is preferred.

  • Working knowledge of current Good Manufacturing Practices (cGMP), and current Good Documentation Practices (cGDP) is preferred.

  • Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:

Leadership Behaviors

  • 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 preferred in engineering with at least 5-8 years related experience in a GMP pharmaceutical environment.

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Working Environment

• 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 be working in a loud area that requires hearing protection and other protective equipment to be worn.

• May work with chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.

• May be required to participate in the Process 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.

Physical Demand

• May be required to lift weight up to 25lbs.

• 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.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.