Assoc. Spclst, Engineering

Associate Specialist, Validation

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

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 Associate 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 Associate Specialist will prepare, 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.

Additional responsibilities include the following:

• Complete deliverables for ongoing Validation activities as assigned to associate 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:

• Preferred BS in Engineering or Sciences

Required Experience and Skills:

• Knowledge and hands on experience with GMP Manufacturing processes.
• Strong communication, collaboration skills and ability to drive accountability.
• Proficiency with Microsoft Office applications (Word, Excel).

Preferred Experience and Skills:

• Experience working on cross-functional team to achieve common goal.
• Experience writing GMP documentation.
• Experience using KNEAT/eVal.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.