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Senior Engineer II - St Albans, United States - St. Joseph's Hospital
Description
Job DescriptionAbout the role:
The Senior Engineer reports to the Associate Director of Manufacturing Sciences.
As a Senior Engineer you will provide process support to the Manufacturing Process by investigating and troubleshooting technical issues within the Social Circle IG Purification and Filling manufacturing facility.
You will assist your quality and manufacturing partners in maintaining process compliance, aiding in the implementation of yield and process improvements, and supporting process validation activities.
How you will contribute:
Ability to solve routine design and engineering tasks.
Prepare for technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.
Evaluate and prepare complex product impact assessments for process exceptions.
Provide training, advice and assistance to team members, manufacturing, and quality regarding analytical and process problems.
Make sound technical recommendations and contribute to technical feasibility analysis regarding projects/matters.
Independently plan and execute a series of design and technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving all products/processes.Evaluate results relative to protocol requirements, definitions and study goals. Provide analytical interpretation of result from studies to stakeholders.
Use statistical analysis to draw appropriate conclusions from the data
Follow quality system, understand and apply applicable corporate, divisional and departmental procedures. Knowledge of related regulations and guidance (e.g., USP, ICH, and regional compendia) to facilitate compliance.
Present information to auditors
Troubleshoot and provide timely resolution to technical issues to support ramp-up and steady-state operations of pharmaceutical manufacturing facilities.
Solve technical manufacturing issues
Work with manufacturing and global subject matter experts to identify improvement opportunities
Work with appropriate teams to execute improvement projects, including validation support and submission writing
May work on small scale experiments
Work with Manufacturing to help promote key metrics such as yields and capacity.
Author and execute process validation protocols and final reports (e.g. process performance qualification, mixing study, hold study, etc). Coordinate and support training and execution of validation activities.
Promote the use of DMAIC tools in problem solving and projects.
Analyze scientific, and statistical data to draw appropriate conclusions.
Mentor and develop team members
Minimum Requirements/Qualifications:
Requires a bachelors' degree in engineering, biochemistry, biotechnology, or related scientific field with 8+ years of related experience.
Knowledge of FDA-regulated manufacturing environments.
Practical and theoretical knowledge of the purification of plasma proteins and biochemistry.
Experience with engineering principles in various scientific disciplines.
Must be willing to learn and develop engineering and project skills.
Must embrace working in a fast-paced, team-oriented, cross-functional environment.
Experience with Minitab or other statistical software preferred.
Experience with DOE (Design of Experiments), six sigma, and lean manufacturing a plus
What Takeda can offer you:
Comprehensive Healthcare:
Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous paid time off for vacation, sick leave, and volunteering
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Professional development and training opportunities
Tuition reimbursement
Important Considerations
At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members.
As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way.
In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.#GMSGQ
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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.
USA - GA - Social Circle - Hwy 278
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Req:
R0096489
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