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Automation Engineer I
Location : Social Circle, GA 30025
Headquarters : Tokyo, Japan
Hiring Mode : Full Time
Experience : Mid Level
- Health insurance
- Dental insurance
- Tuition reimbursement
- Paid time off
- Vision insurance
- 401(k) matching
- You will be a team member of the Automation Engineering group. The Automation Engineering group is responsible to ensure that the manufacturing equipment/systems and Automation systems used in the manufacture, storage, testing, and distribution of Takeda products are fit for purpose in accordance with Takeda standards and industry regulatory requirements.
- You will create and deliver fully tested computer programs and, when required, modify basic computer systems design on schedule, within prescribed resource limits, and in accordance with client requirements and departmental standards. Continue to develop understanding of the computer programming process in both development and maintenance situations and assume an increasingly active role in computer systems design. Support user client inquiries and problems and address operational and program discrepancies. You will implement area and system improvements through strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility.
- Expected to make suggestions on improvements based on supporting data, technical knowledge, engineering principles and current industry practices.
- Lead & Support the planning and execution of medium and large sized capital projects by working in cross-functional teams as technical lead/representative for a specific discipline or area
- Supervise contractors and junior level engineering personnel on projects and activities.
- Assess existing equipment and control systems in the various manufacturing areas and determine the required changes to meet the design, reliability and requirements.
- Develop, design, and review electronic batch records for manufacturing process, support equipment or systems.
- Lead one or more manufacturing process areas, overseeing all investigations and projects in that area.
- Design and implement changes to Electronic Batch Record while adhering to validation and change control procedures.
- Support and/or lead continuous improvement, process optimization, reliability, expansion and upgrade projects.
- Identify, analyze, propose and document appropriate solutions for problems and issues that may impact the project. Identify and understand broader business impact. Determine solutions and escalate when appropriate. Use technical tools (queries, process maps, etc.) for problem resolution.
- Understand and follow appropriate SDLC, quality validation processes and application processes.
- Provide cross-functional and business knowledge to develop business system and process alternatives. Provide strong knowledge of an enterprise/ cornerstone system (such as EBM, JDE, PeopleSoft, Siebel, Metaphase).
- Train others as appropriate on specific area of business or systems expertise. Assist in development of training materials and/or conduct training.
- Update and develop User Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for new and existing equipment and control systems.
- Develop, revise, and execute procedures for various control systems software configuration, hardware installation and back up and restoration.
- Develop and review submittals for technical content in accordance with project requirements
- Continuously stay current with assigned SOPs and keep an up-to-date training file ensuring compliance with all applicable Standard Operating Procedures.
- Bachelor's degree in Engineering discipline required. 5+ years of related experience or Bachelor’s degree in information technology, Sciences, Technology, Mathematic or related technical field and 8+ years of related experience Some leadership experience preferred for supervisory roles.
- Ability to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and Powerpoint) and MS Project.
- Work in a team-based environment.
- Must be a self-starter, detail oriented and able to work independently with minimal supervision.
- Familiarity with business process flow and/or entity relationship modeling. Good communication (verbal/written/listening) skills. Experience with GMP systems and change management process.
- Must have programming skills in technologies used. Knowledge of the systems development life cycle and technology infrastructure. Solid knowledge of the application development process. Strong knowledge of relational databases concepts and querying.
- Must have familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
- Must have basic knowledge in automation of pharmaceutical or food processing facilities.
- Must possess the ability to manage commitments for self and team. Must display eagerness to learn and continuously improve.
- Has the ability to work off shift as needed for issue escalation support.
- Has knowledge of system integration and data historians.
- 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 time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
- Important Considerations
- At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. 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. This may include additional hearing protection for loud areas.
- 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.
- At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
- 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.
- This posting excludes Colorado 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.
USA - GA - Social Circle - Hwy 278