Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.
Every vial has a name is a core value at our Thousand Oaks CA campus, a multiproduct facility with over 20 years of operational expertise. We have an excellent opportunity for a high performing Sr. Project Engineer. The selected candidate must provide thought leadership and demonstrated ability to coach and influence at the executive level and across the broader organization. In addition, the selected candidate must have a proven track record of ensuring safety, quality, delivery and cost are achieved in support of the business strategy.
The Sr. Project Engineer is responsible for all Independently plan and lead the technical elements of mid to large size cross-functional engineering capital projects (or a number of small size projects with complex features). Apply engineering principles to implement solutions in a dynamic, fast-paced cGMP biopharmaceutical environment, from conception to final design and implementation. Plan, schedule, and lead technical elements of engineering project assignments with respect to evaluation, design, selection and implementation using various engineering techniques and good engineering practices. Supervise and coordinate project related contractors and engineering firms/consultants. May also provides technical mentorship and development for the other Engineers within the department.
Essential Duties & Responsibilities
- With minimal guidance and supervision, lead the planning and execution of all technical/engineering aspects of major capital projects related to production and/or facility requirements as the Engineering Lead representative. Expected to make suggestions on improvements based on technical knowledge and current industry practices.
- As engineering technical lead, generate, execute and deliver the following for capital projects: Define project scopes, RFQ/RFPs, detailed scopes of work, technical specifications, design reviews, bidding and selection, FAT/SATs, equipment installation, debugging and optimization, cycle development, Commissioning and Qualification.
- Work with Project Managers to prepare capital project funding requests, including business case development and project execution planning.
- Prepare and/or support preparation of cost estimates, budgets and project schedules for capital projects.
- Drive technical elements of projects to completion and meet objectives of timeline and budget.
- Supervise and coordinate contractors, engineering/validation service consultants and manufacturing/maintenance personnel on assigned projects.
- Plays a role in capital project planning and contributes to spending and tracking to budget
- Creates and updates written standard operating procedures (SOPs), technical specifications and engineering drawings in their core competency to ensure accuracy through periodic reviews and continuous improvement projects.
- Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
- Stay current with industry best practices and technologies.
- 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.
- 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 Substance and/or Fill/Finish manufacturing processes and all supporting equipment.
- Possess expert knowledge of core principles in various engineering disciplines including manufacturing (cell culture/purification/aseptic filling/packaging/cGMP facility design), utility systems (WFI/clean steam/compressed gases/HVAC) and facility design.
- Must have the ability to effectively lead technical projects, coordinate contractors, and drive results
- Must have a demonstrated track record of successfully executing technical projects in an FDA regulated manufacturing environment.
- Has the ability to prioritize multiple tasks and work on multiple projects simultaneously.
- Must be able to provide solutions that reflect an understanding of business objectives and cost implications.
- Knowledge of programmable logic controllers (PLCs), instrumentation and controls highly desirable
- Must have good interpersonal skills and work effectively and efficiently in a cross-functional, team-based environment
- Must display personal accountability for results and integrity
- Must have uncompromising dedication to quality and compliance
- Experience solving problems using the DMAIC methodology
- Able to review cad drawings, 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, FDA and EU regulations.
- Must have very strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and be results oriented.
- Must be able to update procedures and modify processes to simplify their complexity and improve efficiencies.
- 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.
- 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, Chemical or Biomedical Engineering with a minimum of 15 years of experience in an engineering role within a pharmaceutical, biotechnology or FDA regulated industry. A minimum of 5 years experience executing capital projects is preferred.
- Must have experience and be knowledgeable of biopharmaceutical process/equipment sanitary design principles and materials of construction within the following areas: bulk drug substance processing (Cell Culture/Purification), aseptic processing and filling, lyophilization, capping, cGMP facility design and operating principles (cleanrooms, ISO classes, HVAC), utility systems common to the biopharmaceutical industry (WFI, compressed gases and clean steam), clean-in-place (CIP) and steam-in-place (SIP) equipment and cycles, air-handling-units, autoclaves, process instrumentation and controls.
- Must be familiar with cGMPs, Good Engineering Practices, as well as FDA and EU regulations.
- Six Sigma Green Belt / Black Belt Certification is Preferred
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.
May be exposed to sunlight and heat, may work in a cold and wet work environment.
May be exposed to dust, gases, and fumes.
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 work around chemicals such as alcohol, acids, buffers that may require respiratory protection.
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.
This position may require occasional shift, weekend and holiday work.
May be required to work in a confined area as defined by the Environmental, Health, & Safety office
Possible exposure to cool/hot storage conditions.
Will have interaction with other people.
Pace may be fast and job completion demands may be high.
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.
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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.