Provides specialized validation knowledge and information, which is directly required to support operations and clients. Completes all protocols related to the validation of equipment, processes and new products and reviews all finished reports prior to final approval. Ensures documents conform to all Patheon Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices.
- Provides leadership to Validation Scientists (I&II) by delegating projects, training/mentoring, and tracking project progression.
- Prepares and executes protocols and written reports.
- Reviews documents from team members.
- Provides guidance to junior members on various validation requirements (through team meetings and individual interactions).
- Reviews and approves master batch records, deviations and maintenance reports (as qualification is established).
- Attends client meetings as validation representative.
- Updates assigned Master Validation Plans (MVPs) as per validation policy.
- Provides audit and regulatory support.
- Leads / facilitates technical investigations and Corrective Action Preventative Action (CAPA) implementation Supports special projects (as required).
- Performs alternating or rotating shift work (as required).
- B.Sc. in Chemistry, Engineering, or related field.
- Minimum 5 years’ experience in validation within the pharmaceutical industry.
- Previous experience in project management and statistical analysis.
- Ability to work well independently and in a team based environment.
- Lead team members.
- Excellent computer skills (Microsoft Word and Excel).
- Superior writing skills as well strong accuracy and attention to detail.
- Excellent interpersonal skills, communication and organizational skills.
- Strong judgment, decision making and trouble shooting skills.
- Ability to multi-task, meeting tight deadlines in a fast paced environment.
- Proficiency with the English language.