Job Description

Company Description
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

• Ability to travel up to 50% (internationally).
• Candidates may be requested to go through a background check before the interview process.
• Preparing and executing validation documents.
• Project execution for multiple systems validation.
• Understanding the hours budgeted for completion of each task on a specific.
• Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management, and peers.
• Develop Installation, Operational, Performance, and Test Method qualification documents.
• Log deviations and issues found during validation activities and track to closure.
• Write deviation, failure and investigation reports related to the validation activities.
• Interact with cross-disciplinary project teams in order to meet project milestones and end goals.

Qualifications

• Qualified candidates will possess a Bachelor’s degree in Life Science or related field (Mechanical Engineering, Chemical Engineering, Automation Engineering, Computer Science, or similar disciplines) along with 5 plus years of related industry experience.
• Candidates must have excellent verbal communication and technical writing skills.
• Experience in executing protocols including systems such as Process Validation, computer-controlled systems validation, utilities, manufacturing equipment such as computer-controlled filling systems, formulation systems, and basic knowledge of laboratory validation (not required but preferred).
• Familiarity with many aspects of validation is expected.
• Experience with temperature mapping, sterilization validation, and Facility Validation.
• Proficient in Microsoft Word, Excel, PowerPoint, and Project.
• Experienced in and 21CFR211, 21CFR part 820, ISO13485 , 21CFR part 11.
• Ability to travel internationally throughout the US.

Additional Information
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applicants welcome, H1B holders preferred. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***