Validations Specialist

Job Title:  Validation Specialist

Company Name/ Subsidiary: Pegasus Laboratories      

Summary:

The primary purpose of this position is to create and/or update PVMP (Product Validation Master Plans) and VSR (Validation Summery Reports) for annual FDA reporting. Perform cleaning validations, process validations, and packaging validations as needed. This position also helps manage the Product Cleaning Validation life cycle post FDA approval through continued cleaning verification. 

Responsibilities:

• Support Product Validation Master Plans for specific products and projects.
• Independently performs sampling and sample preparation in support of cleaning, (process, and packaging as needed) validation protocols. Must be able to analyze raw data and interpret results.
• Write operation and cleaning procedures to support manufacturing equipment and product lines.
• Helps maintain the overall cleaning validation program in accordance with the appropriate Validation Master Plan.
• Has the ability to work with groups, other departments and independently.
• Monitors ongoing product validation activities to ensure cleaning validations are completed.
• Supports equipment and facility commissioning projects through protocol development and execution of IQ’s and OQ’s.
• Supports the operations in facility environmental monitoring and the calibration program; may work with engineering to track calibration activities.
• All other duties as may be assigned.

Qualifications & Requirements:

• AA degree or professional accreditation or coursework in a relevant field or equivalent experience. BS or MS in a related discipline from an accredited university preferred.
• Experience: 3+ years required with an AA degree or professional accreditation or coursework in a relevant field. 1+ years’ experience with a BS or MS in a related discipline. Experience with FDA regulated manufacturing, facilities, quality, or laboratory environment. Experience with Process Validations, Cleaning Validations, Scale-up, and equipment/facility qualifications are a plus.
• Specialized knowledge or training: Must have a pharmaceutical, cGMP, background with an FDA regulated facility. Familiar with SUPAC, USP, ICH, and VICH guidelines.
• Other Skills: Strong technical writing and documentation skills (cGMP, protocols, reports, system investigations, lab notebooks).
• Travel required in this position 0-10%.