The Engineering Specialist is responsible for all Process Engineering for a designated manufacturing value stream and serves as the areas lead technical subject matter expert for all Process and/or Project Engineering needs. Specifically, the Engineering Specialist implements the life cycle analysis program for all assigned manufacturing engineering assets, acts as an owner (SMEs) for assigned manufacturing equipment, and leads all equipment related investigations and troubleshooting of manufacturing equipment where the root causes is not easily identifiable by the operators or maintenance technicians. The Engineering Specialist also provides technical mentorship and development for the other Engineers within the department.
Essential Duties & Responsibilities
- Helps justify and execute activities that support the repair and upgrade of engineering assets.
- Implements the life cycle analysis program for all assigned manufacturing engineering assets to ensure there is a phased approach to upgrades and replacement of aging assets for all manufacturing equipment.
- Acts as an (SMEs) for assigned manufacturing equipment.
- Identifies and executes value improvement projects to reduce operating costs and improve efficiency in Manufacturing. May support or lead Six Sigma Green Belt and Black Belt Projects following the DMAIC methodology to solve complex equipment and engineering problems.
- Executes processes and systems to measure and monitor equipment performance and use that data to identify trends and improve equipment efficiency.
- Leads all equipment related investigations and troubleshooting of manufacturing equipment where the root cause(s) is not easily identifiable by the operators or maintenance technicians.
- Change control ownership for equipment related changes.
- Identifies new equipment technologies for manufacturing support equipment.
- Mentors and trains other Engineers.
- Ensure a safe & environmentally sustainable work environment is maintained through adherence to EHS guidelines and policies. 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.
- Ensure all mandatory training requirements are met, including annual EHS training, GMP refresher training and any applicable training requirements for all employees.
- Maintain an on-going two-way performance dialogue with manager and meet timelines for completing all mid and year-end reviews and development plans for self and direct reports.
- Maintain a positive, professional and customer-oriented attitude. Communicate any concerns related to safe work practices, hostile work environment, sexual harassment or any other type of employee misconduct directly to the supervisor, manager, or human resources.
- May perform other duties as assigned
- Must be a subject matter expert in Bulk Drug and/or Drug Substance manufacturing processes and all supporting equipment
- Expert knowledge with all HVAC, WFI, CIP, SIP, and utilities systems
- Experience solving problems using the DMAIC methodology
- Able to review blue prints, equipment manuals, specifications, standard operating procedures, and be able to use proper judgment when making engineering related decisions.
- Have working knowledge of hazardous chemicals and their disposal, OSHA, EPA, and FDA requirements.
- Employee maybe required to manage 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.
- Must have very strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.
- Must be able to update procedures and modify processes to simply their complexity and improve efficiencies.
- Must be results oriented with a high level of energy
- Must be able to challenge the status quo and lead organizational change
- Passion for Improving Lives: Must be able to put our patients at the center of everything we do.
- Quest for Innovation: Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.
- Inspired Teams environment: Must be able to thrive in diverse high performing teams.
- Engaged with the World Around Us: Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.
Education and/or Experience
- BS degree in Mechanical or Chemical Engineering. Minimum of 15 years experience in engineering within a pharmaceutical, biotechnology or related industry.
- Six Sigma Green Belt / Black Belt Certification is Preferred
Must be able to lift, push, pull and carry up to 50 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.