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Qualified candidates must possess relevant experience in one or more of the following areas of validation and be considered a Subject Matter Expert in one area:

• Equipment Qualification

• Process Validation

• Test Method Validation

• Cleaning Validation

• Statistical Sampling

• Responsibilities associated with this position are directly associated to conducting validations related to new product introduction (NPI), product transfers, and other validation projects.

• Well organized and technically sound in understanding scientific rationale and justifying acceptance criteria from a quantitative standpoint.

• Understand risk-based sampling. Candidate must possess sufficient knowledge and experience to serve as a subject matter expert within one area of validation.

• Be a team player who thrives in a team environment, but also has the capability to work on their own to research and investigate. An understanding of cGMP environments is required.

• Understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.

• Determine scope and path forward for validation requests.

• Must be able to read and understand engineering P&ID's and turnover documentation.

• Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.

• Serve as validation representative on cross functional teams for transfer, NPI, and other projects as necessary including supervision of contract validation resources.

• Experience of utility qualification, equipment qualification, process validation, packaging validation, distribution studies, aging studies.

• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

• Ensure compliance in area of subject matter expertise across the company.

• Support and address comments and suggestions associated with validation and engineering documentation.

• Change control, non-conformance and CAPA support.

• Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor's degree in engineering (Quality, Mechanical, Chemical, or Electrical) or Science (Biology, Chemistry) in preferred.

• 4-7 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.

• Demonstrates excellent organizational and communication skills.

• Results oriented with a strong focus on quality principles.

• Excellent technical writing skills with an understanding of good documentation practice.

• Experience conducting validation studies and managing projects independently.

• Ability to track milestones and manage validation projects.

• Working knowledge of applicable regulations and their interpretation within industry.