Support day to day operation of the plant manufacturing process and equipment issues, focus area to be Formulation, Filling & Finishing. Study and provide techniques to improve existing process to minimize cost and increase efficiency. Lead all equipment related investigations for autoclaves, parts washers, filling and packaging machines, lyophilizers, etc. Support manufacturing equipment life cycle. Contribute to developing improved and robust control strategies for manufacturing processes. Required to rely on experience and judgment to plan and accomplish goals with minimal supervision.
- Ability to prioritize multiple tasks from multiple customers.
- Lead process improvement projects through implementation, including training on new processes and measure systems.
- Perform standard engineering assignments which are typically a significant portion of a larger project. Select sound techniques to solve problems and make design recommendation under direction of supervisor. Assess results for application, validity and conformance to specifications. Recommend material and process specifications.
- Study and recommend techniques to improve existing products/processes to improve production efficiency and to reduce cycle time. Provide suggestions on how to improve an existing process if needed.
- Provide technical expertise for troubleshooting manufacturing process and equipment problems.
- Utilize engineering tools to solve straightforward problems
- (e.g., FMEA, Process Modeling, Design of Experiments, software development).
- Monitor and report project costs including capital and cross-functional expenses. Estimate cost affected by design and/or policy changes. With supervisor, recommend capital expenditure and production methods for existing or enhances products or processes.
- Investigate new sources for raw materials or processes.
- Determined basic causes, develop recommendations for corrective action, and follow-up to ensure completion of corrective action.
- With supervisor, formulate and recommend engineering policies and technical work in accordance with project and business objectives.
- Responsible for all manufacturing equipment life cycle.
- Analyze how process changes will effect overall production and the product.
- 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.
- May perform other duties as assigned.
Education & Experience Requirements
B.S. in Engineering (preferably in Mechanical, Electrical, Chemical or Biomedical Engineering) or equivalent. 3-5 years related experience (in-house, co-op or acquired outside) in a GMP pharmaceutical environment. Good technical writing skills are required. The candidate must have good communication skills and the ability to perform effectively in multi-disciplinary teams
Key Skills and Competencies
- Good understanding on Filling Machines (Isolator and RAB technology), Capping Machines,
Parts Washers, Autoclaves, Lyophilizers, Packaging Machines and Aseptic processes.
- Knowledge of the basic principles in various engineering disciplines.
- Must know how to effectively run projects, coordinate contractors, and direct the activities of technicians. Must have the ability to organize and present technical and project management overviews without assistance.
- Knowledge of cGMP manufacturing and GEP.
- Knowledge of pharmaceutical production equipment including autoclaves, formulations tanks, filling machines, capping machines, CIP/SIP systems.
- Must be able to provide solutions that reflect understanding business objectives and cost implications.
- Must have good verbal/written communication skills
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, and pragmatism.
- Must have passion to innovate and drive for solutions.
- Must display personal accountability for results and integrity.
- Must display eagerness to learn and continuously improve.
- Must have uncompromising dedication to quality.
- Must have relentless focus on rapid and disciplined action.
- The position requires shift, weekend, and holiday work.
- Employee maybe required managing hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
- Demonstrated understanding and compliance in Standard Operating Systems, Current Good Manufacturing Processes (cGMP) & Good Documentation (GDP).
- Support planning and scheduling activities as directed.
- Requires familiarity with generally accepted building, plumbing, piping, electrical, and fire protection practices and codes to include NFPA, NEC, UBC, UMC and UPC in compliance with Takeda EH&S and Factory Mutual requirements.
- Must follow safety rules and ensure compliance with CA state and federal EPA regulation and laws. Specific responsible system repairs, upkeep, maintenance and operations managed within regulating agencies such as CAL OSHA and OSHA.
- Ensures personal Training Plan execution and compliance. Attends required training, meetings, and QWTs. Interact with and oversee contractor/vendor work
- Ensure safety, security, and the environment in all aspect of the daily activities and any potential safety hazardous are addressed and corrected immediately.
- Understand ergonomic relationship between people, equipment and working environment.
- Communication with customers, and daily communication and interaction with Supervisor regarding all daily activities.
- Adhere to all SOP s during execution of daily work tasks.
- May be required to participate on call rotations for facilities/manufacturing/utilities support.
- Provides support for regulatory, partner and internal audits.
- May be responsible for development, revision and review of maintenance reports forms, records and/or procedures.
- Maybe provide training for staff as needed.
- 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
Other Job Components
- Must be able to work more than 8 hours a day or 40 hours a workweek as required.
- Must be able to 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.
- The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
- May work in a cold, wet environment.
- May be exposed to sunlight and heat.
- May be exposed to dust, gases, and fumes.
- Possible exposure to cool/hot storage conditions.
- May be around moving equipment and machinery.
- May climb up and into large processing tanks for cleaning or inspection.
- May be working in a loud area that requires hearing protection and other protective equipment to be worn.
- May be required to work in a confined area as defined by the Environmental, Health, & Safety office.
- Inside working conditions.
- Will work in a cold, wet environment and hot humid environments both inside and outside of facility.
- Will work around chemicals such as paint, flooring materials, refrigerants, alcohol, acids, buffers that may require respiratory protection.
- May be required to travel for business reasons, e.g. training or FAT.
- Pace may be fast and job completion demands may be high.
- Must be able to lift, push, pull and carry up to 25 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
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, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, 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.