Validation Manager

Bend, Oregon /
Manufacturing Science and Technology – Validation /
Full-time Exempt
/ On-site
Serán BioScience is looking for a leader to help mentor and shape the team of validation engineers and operators for the development and manufacturing of novel drug therapies. Validation is a regulatory requirement and must be conducted in conformance to cGMPs and FDA requirements.  The Validation Manager will be part of a cross functional management team that will develop the validation programs for process, cleaning, computerized systems, and qualification of equipment and critical utilities needed to support clinical and commercial distribution of sterile and non-sterile pharmaceutical products.

The Validation Manager will be responsible for management of validation programs, which requires a thorough understanding of the processes and systems to be studied as well as an understanding of all applicable regulations, guidelines, policies, procedures, and requirements.

The development and management of validation programs 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 under MS&T (to include recruiting, hiring, training, mentoring, coaching, onboarding and discipling, team building, etc.)
    • Lead cross functional internal and external teams during execution of validation projects 

Duties and Responsibilities

    • Develop validation programs to support projects for new product introduction, tech transfer, product / process optimization in the Commercial Manufacturing facility
    • Manage the validation programs in conformance with all applicable guidelines, policies, procedures, and requirements
    • Author validation protocols and reports
    • Coordinate training and execution of validation studies
    • Work with internal and external teams to enhance current Quality and Technical systems supporting product development projects transitioning from Phase 2/3 clinical to registration as part of technology transfer, and using Product Lifecycle concepts
    • Manage department and/or project budgets
    • Other related duties as assigned 

Required Skills and Abilities

    • Knowledge of cGMP and Global Regulatory (E.g., FDA / MHRA / EMEA) guidelines and regulations acquired through education, experience, and training
    • Understand the Compliance and Technical requirements on the application of various scientific concepts used for developing different dosage forms of pharmaceutical products (primarily oral solid dose)
    • Knowledge of 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 10 years’ experience in developing and executing equipment qualification, process, cleaning, computerized systems validation projects in a Quality Assurance or Technical Services capacity
    • Five or more 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
    • Three or more years of experience as a CMC resource for Pre and Post Approval Regulatory submissions and validation
    • Level and compensation will be commensurate with education and experience

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