Validation Specialist

The Validation Specialist is responsible for the development of the formulation for various pharmaceutical products. The Validation Specialist actively participates in all the phases of the development including the pre-formulation, formulation development, process development, scale-up, technology transfer and process validation.

Key Responsibilities include but are not limited to:

• The Validation Specialist will perform installation, operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems such as planning, coordination, development, execution and close out of qualification and/or validation protocols/reports meeting quality and schedule expectations
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  Additional responsibilities include but are not limited to: support cleaning development activities, creation of standard operating procedure, provide technical training, audit GMP documentation, investigation, Gap/Risk assessments and troubleshooting and/or providing recommendation to resolve issues or to optimize qualification activities, As needed, the position will also support the cleaning validation, verification activities
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  This includes FAT/SAT, URS, FRS, DQ, Risk Assessments, IQ, OQ/PQ, and other validation life cycle documents
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  Assist in cleaning validation activities at the site, which includes development of validation protocols, testing execution and closure of validation reports
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  Follow GDP practices while developing qualification packages
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  Assists with the site change management program to keep the equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings
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  Stay current with industry qualification trend through FDA, ISPE, EU PDA and bench mark with industry standards
• Ensuring all regulatory documents in compliance with SOPs, FDA Regulations and cGMP policy where applicable.
• Maintaining compliance with GMP, SOPs and DEA regulations.
• Other duties as assigned.

Qualifications and Requirement:

• Bachelor degree in relevant scientific discipline or equivalent required
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  3 years of experience in pharmaceutical or any regulated industry, A combination of education and relevant experience will be considered
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  Understanding of validation and qualification principles, and quality system principles (change control, non-conformance and CAPA)
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  Knowledge of cGMP, FDA Regulations, WHO standards, ICH-Q8, Q9 and Q10, and other applicable industry regulations and standards
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  Ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and operations/engineering staff
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  Ability to read, analyze and interpret common scientific and technical journals; comprehend equipment manuals and translate operational limits into protocols acceptance criteria
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  Working experience qualifying any of the OSD/Sterile Manufacturing and Packaging equipment, facilities and utilities
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  Legal authorization to work in the US is required

WHY SHOULD YOU WORK WITH AAVIS?

Competitive Pay

Medical, Vision, Dental insurance benefits

Lots of Free Merch (Apparel, stationery mugs, tumblers, totes, etc )

401k Benefits with 4% company match

Front Loaded PTO Days

Company wide recreational events

Free snacks

Paid Maternity/Paternity leaves

Amazing Advancement opportunities

So much more...