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.

Primary Job Responsibilities:

• Verification of / adherence to related Inventprise quality system validation requirements.
• 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.)

Qualifications:

• Bachelors degree in the sciences, preferably Engineering.
• 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 Requirements:

• 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.
• Potential for light lifting, as part of validation protocol execution.
• Must maintain continuous levels of accurate mental acuity, while processing validation related data and documentation.
• Requires substantial analytical skills for related investigatory and problem solving assignments.

Required Experience:

• Minimum 3 years work experience in the FDA regulated industry, in pharmaceuticals or biotech.
• Basic computer skills, Microsoft Word, Excel, etc.
• Experience writing and executing validation protocols for major pharmaceutical manufacturing equipment, with additional software validation experience preferred.

Inventprise is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.