Head of Systems Validation
Bend, Oregon /
Manufacturing Science and Technology – Systems Qualification /
Full-time Exempt
/ On-site
The Head of Systems Validation will be part of a cross functional management team that will develop the validation programs for facilities, utilities, equipment, and computerized systems needed to support clinical and commercial distribution of sterile and non-sterile pharmaceutical products. Validation is a regulatory requirement and must be conducted in conformance to cGMPs and FDA requirements.
The Head of Systems Validation will be responsible for management of validation programs specific to systems. This position requires a thorough understanding of the processes and systems to be studied as well as all applicable regulations, guidelines, policies, procedures, and requirements.
The development and management of validation programs for systems used for GMP operations and the execution of validation studies requires direct communication with internal and external cross functional teams. Effective communication is essential for extracting required information, alignment of strategies and approaches, and correcting deficiencies while maintaining good working relationships.
Supervisory Responsibilities
- Manage the Validation Engineers responsible for execution of projects to validate facilities, utilities, equipment, and computerized systems under MS&T
- Support the department head in recruiting, hiring, training, mentoring, coaching, onboarding and discipling, team building, etc.
- Lead cross functional internal and external teams during execution of validation projects for systems supporting GMP operations
Duties and Responsibilities
- Develop validation programs for facilities, utilities, equipment, and computerized systems needed to support projects for new product introduction, tech transfer, product / process optimization in the Commercial Manufacturing facility
- Manage validation programs for facilities, utilities, equipment, and computerized systems in conformance with all applicable guidelines, policies, procedures, and regulatory requirements
- Provides input in the development of strategy, procedures, and policy development within the organization
- Demonstrate capability of developing and recommending strategies for change while effectively communicating the rationale for the changes
- Ability to negotiate and influence internal and external customers
- Proactively identify, communicate, and monitor regulatory changes that could have an impact on quality or compliance within the organization
- Manage department and/or project budget
- Other related duties as assigned
Required Skills and Abilities
- Knowledge of cGMPs and Global Regulatory (e.g., FDA / MHRA / EMEA) guidelines and regulations acquired through education, experience, and training
- Experience interacting with regulators and clients during audits
- Understanding and hands on experience with Software as a Service (SaaS), associated compliance concerns and validation approach
- Understanding of automated testing for computerized systems validation
- Knowledge on Regulatory expectations and Industry practices for Validation using Product Lifecycle approach
- Effective written, oral, and interpersonal communication skills
- Excellent leadership skills with ability to motivate and coach employees
- Strong time-management skills and the ability to organize and coordinate multiple projects at once
- Proficiency in enterprise systems, Microsoft Office and other office productivity tools, with aptitude to learn new software and systems
Education and Experience
- Bachelor’s degree in a scientific discipline or another discipline with equivalent experience and training
- A minimum of 15 years of overall experience in the pharmaceutical / biopharmaceutical industry
- A minimum of 10 years of qualification experience with equipment, facilities, and equipment qualification and 5 years of experience of computerized systems validation
- A minimum of 5 years of experience in pharmaceutical process development and/or technology transfer, clinical and commercial manufacturing of non-sterile and sterile products and scale-up of approved products
Physical Requirements
- Prolonged periods of sitting at a desk and working on a computer
- Prolonged periods of sitting or standing in a manufacturing environment
- Must be able to lift fifteen pounds at times
