This position reports directly to the Engineering Director. The role is responsible for evaluating and validating the equipment and procedures used in development and production of a variety of products. Additionally, this role ensures all systems are running according to necessary specifications and operates within regulations to ensure the production of quality products for the Company’s 503B cGMP manufacturing facility.
- Ability to take ownership and accountability for the Validation function across multiple fast paced projects.
- Computer System Validation (CSV) experience with process control and automation systems
- Experience with automation, commissioning, qualification or operations in a cGMP environment.
- Direct experience developing validation protocols and execution of protocols.
- Knowledge of current industry standards such as GAMP5 and ASTM E2500.
- Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.
- Excellent client communication skills.
- Schedule, plan, manage and execute studies for cleaning verification and validation.
- Review and approve validation project documentation.
- Coordinate and interface with the process unit heads, quality and engineering groups for assuring successful project execution.
- Lead and coordinate cross-functional teams for project validation.
- Prioritize, manage, and execute multiple projects utilizing the project management methodologies.
- Support the development of best and proven validation practices in the validation department, based upon current industry guidelines and practices.
- Author relevant standard operating procedures for ensuring compliance with the company’s policies.
- Support regulatory submissions and regulatory agency inspections whenever required.
Supervise external resources for completion of critical tasks.
EXPERIENCE AND NECESSARY SKILLS:
- Bachelors’ degree in life sciences or engineering or relevant fields preferred
- At least 5 years of experience in a highly regulated environment like biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements.
- Experience in project management.
- Knowledge of cGMP requirements as they pertain to the validation of manufacturing and lab equipment in a pharmaceutical environment.