Validation Engineer

Job Title: Validation Engineer
Location: Round Lake, IL

About the role:

This position will perform validation activities for site and global projects.  The position will author and execute commissioning, qualification / validation protocols and final report documents.   The responsibilities include risk assessment, equipment, utilities, facilities, computer system, and cleaning, as applicable.

Primary tasks include development of protocols, test execution, data entry /review, preparing final reports and assembly of final validation packages.  Responsibilities consist of initial validation, revalidation and project support. 

This position will work in close cooperation with the manufacturing, engineering, Quality Assurance and Quality Operations on a day-to-day basis.

How you will contribute:

Applies understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate.

Performs a variety of studies in several areas at the same time to support multiple protjects.

Handles routine tasks with attention to detail, timely and accurately.

Participate and interface with cross-functional project team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements.

Help determine validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and validation. 

Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards (GMPs, FDA, EU and JP Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, USP-NF, etc.).

Assist / support, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions.

Use validation test equipment, such as, Kaye Validator and Ellabs loggers in support of validation activities.

Perform other duties as directed by supervisor.

Must be proficient in written and oral English.

Highly skilled in MS Office: Word, Excel, PowerPoint.

What you bring to Takeda:

Typically Requires:

BA or BS degree preferably in the engineering or science field.

Minimum 2+ years validation experience. 

Experience in manufacturing processes and control systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens), cleaning processes, process materials, process equipment, facilities and critical support systems are required, as applicable

Desired:

Experience working in a manufacturing environment.

Familiarity with control systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens), cleaning processes, process materials, process equipment, facilities and /or utilities

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 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:

In general, the position requires a combination of sedentary work and walking around observing conditions of the facility.

Must be able to occasionally carry up to 30 lbs.

Must be able to stand and/or walk for an extended period over an 8-hour shift.

May occasionally require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.

Indoor working conditions.

Will work around moving equipment and machinery.

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.

Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

May work in a cold, hot or wet environment.

May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

Must be able to occasionally work non-traditional work hours, including weekends and holidays, as needed.

More about us:

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.