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Job Description
Under the direction of the Head of Process Engineering, this position is responsible for providing support for operations and projects for manufacturing at the Rancho and Lawrence Manufacturing Facilities in Thousand Oaks. Establish engineering discipline and practices that support operations while improving functionality. Responsible for the engineering aspect of the process and equipment with regards to projects, manufacturing issues, troubleshooting, investigations and improvements. Ensures cGMPs, SOPs, Company Procedures, and Good Engineering Practices are appropriately integrated in all activities.
Essential Duties and Responsibilities
Applies engineering principles to the design and implementation of major system modifications, process and/or capital projects.
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.
Qualifications
Good understanding on Packaging Machines and Aseptic processes, Single- Use Equipment, Filling Machines (Isolator and RAB technology), Capping Machines, Parts Washers, Autoclaves, Lyophilizers, CIP/SIP Systems.
Knowledge of the basic principles in various engineering disciplines.
Must know how to effectively run projects, qualify equipment, 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.
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.
Education and/or experience
B.S. in Chemical or Biomedical Engineering. 5 -10 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.
Physical Demand
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.
Working Environment
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.
This job posting excludes CO applicants.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
