Employer Industry: Biopharmaceuticals

Why consider this job opportunity:
- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees
- Opportunity to participate in short-term incentive programs
- Engaging work environment focused on innovation and quality assurance in healthcare
- Potential for professional growth within a leading biopharmaceutical company
- Work with cutting-edge technology and contribute to impactful healthcare solutions

What to Expect (Job Responsibilities):
- Provide validation support to project managers for applications throughout the System Development Life Cycle process
- Ensure software quality assurance during IT projects, reviewing validation deliverables for consistency with defined practices
- Manage validation activities including protocol writing, document review, and resolution of problem reports
- Act as a liaison between the IT department and other Quality Assurance departments
- Interface directly with FDA and other regulatory agencies during audits

What is Required (Qualifications):
- Bachelor’s Degree in Science, Engineering, or a related discipline
- 5+ years of experience in validation, systems testing, IT implementation, quality assurance, or software quality engineering in a regulated healthcare industry
- Technical experience in areas such as Chemistry, Pharmacy, Microbiology, Engineering, and Computer Science
- Knowledge of Quality Control/Assurance, GMP regulations, and new product development
- Experience in software development and software testing is desirable but not required

How to Stand Out (Preferred Qualifications):
- ASQ certification in Software Quality Engineering is desired but not required
- Two years of combined experience in software development and software testing

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