Spclst, Engineering

Job Description

Our Engineers support internal and external manufacturing operations, ensuring continuous improvement and innovation. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. 

The Specialist, Validation, will be responsible for completion of validation execution activities at the West Point site as part of the Bio-Sterile Validation (BSV) team. The primary responsibility of the individual will be providing validation support to the Integrated Product Teams (IPTs). The Specialist will prepare, review, approve and execute validation documentation (including but not limited to; protocols, periodic assessments, and final reports) related to new or existing manufacturing sterile projects to ensure successful completion is in alignment with West Point validation requirements. Also, when required the Sr. Specialist will be required to train other Validation personnel.

Additional responsibilities include the following:

• Manage validation needs and deliverables for ongoing Validation activities as assigned to specialist.

• Work closely with IPT management to ensure safe, on-time, and correct execution of validation activities.

• Interface with site Validation SMEs to ensure validation practices are aligned with our Company network.

• Support site IPTs during investigations and troubleshooting.

• Support all aspects of the Continuous Validation Program

Education Minimum Requirements:

• BS, Preferably in Engineering or Sciences

• Minimum of 1 year relevant work experience, hands on experience on validation activities on sterile products manufacturing and/or laboratory operations.

Required Experience and Skills:

• Knowledge and hands on experience with Validation processes.

• Familiarity of different types of Validation applications.

• Familiarity of compliant validation testing techniques.

• Strong communication, collaboration skills and ability to drive accountability.

• Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).

Preferred Experience and Skills:

• Minimum of 2 years work experience within Commissioning and Qualification.

• Experience working on cross-functional team to achieve common goal.

• Experience writing validation assessments.

• Experience using KNEAT/eVal.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.