Senior Validation Engineer - Woodinville, United States - Inventprise LLC

Description

Title: Senior Validation Engineer

Overtime Status: Exempt

Employment Status: Full-Time

Pay Range: $85,000 - $105,000 /yearly

The hiring pay range for this position is $85,000 to $105,000 per year based on skills, education, and experience relevant to this role.

Inventprise is a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. Inventprise is led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.

At Inventprise, we believe our people are our most valuable asset. We are strongly committed to a range of workplace programs that support the well-being, growth, and engagement of our employees and our business. What we offer:

Benefits:

Effective the first of the month following the date of hire, employees are eligible to participate in the following Inventprise employee benefit programs:

• Medical, Dental, Vision, FSA, or HSA: Currently Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents. Medical plans are currently provided through Premera Blue Cross.
• 401(k) program: Inventprise contributes 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
• Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
• Paid Holidays: Inventprise offers 7 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, Christmas Day and two floating holidays.
• Stock & Bonus Plans: Employees are eligible to participate in the Company's Bonus and Stock Award Plans.

Summary:

Essential Functions:

• Verification of / adherence to related Inventprise quality system validation requirements. This includes, but is not limited to, authoring, approving and executing validation protocols in accordance with Inventprise validation procedures, as well as FDA guidances for process validation, manufacturing equipment validation and the associated guidance for aseptic processing of sterile pharmaceutical product.
• Preparation of required IQ / OQ / PQ protocols and data reports, as needed.
• Tracking progress against / updating Validation Master Plan (VMP).
• SME for related validation training and validation reviews / project planning.
• Principle Investigator validation related excursions.
• Quality representative supporting related GMP drawings, drawing system and change control.
• Conducts internal validation protocols for selected items as assigned (e.g. temp mapping, etc.)

Education & Experience:

• Bachelor's degree in the sciences and / or technical disciplines, preferably Engineering.
• Minimum 3 years of work experience (consistent with Essential Function responsibilities noted above) in the FDA-regulated industry, in pharmaceuticals or biotech.
• Detailed familiarity with FDA guidance on process validation, equipment validation and the associated FDA guidance for aseptic processing.
• Basic computer skills, Microsoft Word, Excel, etc.
• Experience in authoring, approving and executing validation protocols for major pharmaceutical manufacturing facilities, utilities and equipment, with additional software validation experience preferred.
• Proven written and verbal communication skills.
• Must have analytical, problem-solving skills, and attention to detail.
• Ability to work in a team environment and take supervision to enact assigned projects.

Physical & Mental Demands:

• Extended periods of time standing and walking in the user environment (e.g. manufacturing, laboratories).
• Requires ability to don and maintain sterile gowning paraphernalia, without introducing potential for microbial contamination.
• Extended periods of time on the computer.
• Must maintain continuous levels of accurate mental acuity, while processing validation related data and documentation.

Inventprise is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.