For the oversite of the sites Validation program ensuring equipment and systems remain in a qualified, operational state of compliance associated with cGMP manufacturing.

Responsibilities:

·       For the oversite of the sites Validation program ensuring equipment and systems remain in a qualified, operational state of compliance associated with cGMP manufacturing.

·       Leads continuous quality system improvements for the validation program.

·       Write and execute Validation protocols such as Installation, Operation, Performance and Cleaning Qualification documents.

·       Work closely with Engineering / Facilities, Equipment End Users, and Quality Assurance to investigate and resolve non-conformances encountered during qualification activities.

·       Assist in investigating deviations related to facilities, utilities, and equipment.

·       Participates in multi-functional department teams for facilities, utilities, and equipment to meet established project timelines.

·       Write and revise Standard Operating Procedures (SOPs).

·       Identify gaps in existing program and devise approaches to improve them.

·       Ability to work in a fast-paced, dynamic, and innovative environment.

·       Work with limited supervision and take ownership of projects to achieve schedule, financial and technical goals. 

·       Maintain accurate and thorough records.

·       Other duties may be assigned as required.

Requirements:  

BS in Engineering (chemical or mechanical) with 5+ years of related field/experience or AS in Engineering (chemical or mechanical) with 10+ years of related field/experience or Non-degreed with 15+ years of related field/experience.
Working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, and pharmaceuticals.
·       Understanding of commissioning / qualification / validation principles.

Experience authoring and executing Validation protocols such as Installation, Operation, Performance and Cleaning Qualification documents.
Experience working in a cGMP environment.
·       Excellent interpersonal and communication skills (verbal and written) are required.

·       Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.

·       Experience with investigating deviations related to facilities, utilities, equipment, and systems.

·       Experience working with multi-functional department teams to meet timeframe for project implementations.

·       Experience writing SOPs.

·       Ability to lead continuous quality system improvements for the validation program.