Senior Engineer II, Quality Validation
Responsibilities
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:
- Packaging Validation
- Equipment Qualification
- Process Validation
- Test Method Validation
- Cleaning Validation
- Utility / Clean Room Validation
- Temperature Mapping Studies
- Statistical Sampling
Responsibilities associated with this position are directly associated to review and support validations related to new product introduction (NPI), product transfers, and other validation projects.
Requirements
The candidate must be well organized and technically sound in understanding scientific rationale and justifying acceptance criteria from a quantitative standpoint. The candidate must understand risk-based sampling.
The candidate must possess sufficient knowledge and experience to serve as a subject matter expert within one area of validation. The candidate must 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 clean room practice and cGMP environments is required. The qualified candidate must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.
Qualifications
- Bachelor's Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry) or a closely related technical discipline is required.
- 1-3 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.
Pay
Pay Range: $94,300.00 - $129,950.00 USD