Job description
We are seeking an experienced Sr. Validation Engineer focusing on filling and packaging production equipment in a GMP facility for formulated liquid OTC, Personal Care, Cosmetics, Consumer Products.
The chosen candidate will provide Validation support for current equipment and manufacturing processes with a focus on packaging equipment. This includes but is not limited to developing gap analysis to determine new validation requirements which will be presented to project leadership and lead the implementation of new validation protocols across a network of manufacturing sites.
Primary Responsibilities:
- Assess the current equipment and processes
- Determine deficiencies compared to our SOPs
- Identify specifically where and what equipment requires Validation, as compared to our risk assessment
- Create a new Validation Protocol for use with our current network of Contract Manufacturers, and for new Contract Manufacturing sites coming into the network
- Lead the implementation of new Validation Protocol across the network of 15 manufacturing sites
- Identify and Ensure all Validation Documentation is complete as required
Types of equipment:
- Blending/batching equipment
- Mixing Tanks
- Mixing blades
- Granulators
- Pumps
- Filling equipment
- Bottle Capping / enclosures
- Labelling machines
Location:
Primarily remote. Must be open to some travel to Contract Manufacturing Sites
Requirements
Must have experience writing Validation documents, and SOPs for new and existing equipment in a GMP facility.
- Bachelor of Science in Engineering or Bachelor of Science in a related field.
- Industry experience in either formulated OTC, Cosmetics Personal Care Consumer Product, Biotech, Pharmaceutical,
- Experience in writing and execution of IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment
- Experience with Validation for Filling and Packaging Equipment as described above
- Experience in GMP/Validation with knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and regulatory requirements
- Proficient in Microsoft Office applications
- This role is primarily remote, but will require some travel to Contract Manufacturing Sites
Benefits
A comprehensive benefits package which includes medical, dental, vision, disability and life insurance, 401k and a generous PTO Policy.
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