Project Manager / Senior Project Manager
ValSource Inc.Highlight
Summary
About the Role
About You
- Minimum of 10 years experience in validation/quality service and project management of life sciences, biotech, or FDA regulated projects.
- Knowledge of Industry guidelines (ISPE, PDA) and US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
- Strong organizational, writing, and communication skills.
- Ability to work independently and in a team environment.
- Proficiency with Microsoft Office including Word, Excel, and PowerPoint.
- Strong understanding of EPCMV, Quality by Design, and risk-and science-based approaches for compliance.
- Experience in leading project teams related to commissioning and qualification of clean/dirty utilities, HVAC, facility systems, process support systems, and process equipment.
- Proficiency with Microsoft Project and Visio.
Benefits
- Competitive compensation package with full benefits including 100% employer paid medical, dental, vision, short- and long-term disability.
- 401k, paid time off (holidays and vacation), continuous training and development.
- Employee Stock Ownership Plan (ESOP), discretionary bonus.
Since 1996, ValSource has worked with hundreds of pharmaceutical, biopharma, and medical device organizations around the world. Our subject matter experts have made significant contributions to the knowledge and skill-base of these highly regulated industries by writing books, publishing articles, leading the development of regulatory guidelines and pharmacopeial monographs, heading professional organizations, and training health authorities.
Whether getting a new site commissioned, qualified, validated, and ready to pass a stringent inspection, or helping a company streamline its development activities by emphasizing an integrated quality risk management effort, ValSource has the knowledge, skills, and experience to help your organization successfully achieve its goals.