Validation Engineer I

Validation Engineer I

Vacancy expired!

Job Description

The Validation Engineer I designs and develops validation protocols in addition to provides expertise to associated equipment and automation design/modifications.

Additional responsibilities include but are not limited to:

• Coordinates Equipment & Cleaning Validation Protocols (development & management) for specific equipment areas – including presentation of technical training & support to personnel, with on-floor guidance.
• Leads validation innovation project efforts requiring cross-functional & contract resources.
• Completes project management tracking of deliverables for metrics & reporting.
• Authors sections of Validation-related reports & project plans provides technical evaluations of validation requirements for core change controls & associated action plans.
• Provides input & validation expertise to Technology Transfer & project/area support efforts.

Qualifications

• Bachelor's Degree in a relevant discipline (preferred) or an equivalent combination of education and experience
• One to two (1-2) years related experience in cGMP.
• Validation and/or Engineer experience is highly preferred.
• Oral Solid Dosage experience preferred.
• Industry Knowledge on GMPs and FDA audits
• Experience in Cleaning and Equipment Validation Philosophy
• Knowledge and experience with Kneat (preferred)
• Practical knowledge and application of GMP and EMEA regulations
• Experience in pharmaceutical or biotech manufacturing environment

Additional Information

This opportunity is in Biogen’s Validation team and coordinates & supports validation related to the manufacturing equipment; provides on the floor execution support, tracking, and updates by performing duties personally or through subordinate supervisors.