Director, Validation

Civica Rx•Petersburg, VA

About The Position

This position will build and lead the Validation function at the Petersburg, VA manufacturing site. The Director of Validation is responsible for developing and implementing the validation strategy for the site and leading the Commissioning, Qualification and Validation activities to ensure facilities, utilities, and equipment are qualified based on intended use. In addition, they will develop the cleaning validation strategy. We are seeking an exceptional leader who thrives in a fast-paced environment to oversee the Validation function.

Requirements

A minimum of a bachelor’s degree or similar technical degree is required.
10+ year’s progressive experience in validation or related role in the pharmaceutical industry.
7+ years of subject matter expertise with validation execution.
3+ years of experience as a primary SME with regulatory inspections.
Extensive experience working in sterile manufacturing, cleanroom, and cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
Experience with CQV, cleaning validation and aseptic process simulations.
Ability to manage diverse teams to execute on the floor activities such as SAT, FAT, IQ/OQ/PQ, CIP, SIP as well as Engineering and PPQ batches.
Subject matter expertise with Data Integrity.
Excellent oral and written communication skills, including presentations.
Ability to explain complex technical issues to key stakeholders and regulatory agencies.
Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
Excellent project management and time management capabilities; with the ability to partner and influence across a matrixed environment.

Nice To Haves

SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator).
Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
Experience with process validation and continued process verification.
Demonstrated management and delivery of large capital projects.
Subject matter expertise with Computerized Systems Validation (CSV)
Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup.
Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.

Responsibilities

Develop the validation strategy for the site and maintain the Validation Master Plan.
As a member of the site leadership team contributed to the strategic initiatives and operational plans for the site.
Implement validation policies and related procedures based on regulations and industry standards.
Oversee the authoring and review of SOPs, protocols, reports and Validation Master Plans for cGMP equipment, utilities, cleaning, analytical methods and instruments.
Implement and manage cleaning validation programs. Plan validation efforts using a risk-based approach.
Provide oversight and direction to Aseptic Processing Simulation (APS) and Air Visualization Studies.
Lead Change Control activities and support Tech Transfers to ensure validation activities are identified to support new and existing products.
Mentor, coach, train and develop validation staff.
Provide training on validation policies, procedures and requirements.
Effectively interact and collaborate with cross-functional departments and vendors to drive validation deliverables.
Serve as subject matter expert in all aspects of validation.
Establish and maintain continuous improvement projects.
Participate in regulatory inspections (e.g. FDA, DEA) as a Subject Matter Expert (SME).
Demonstrates strong leadership, motivation, teambuilding, communication, and advanced coaching skills that instill a strong sense of mission in a team environment across all levels of organization.
Implement and maintain Data Integrity Controls to ensure data is protected throughout the data lifecycle. Maintain Part 11 / Annex 11 compliance.
Forecasts and adheres to departmental budget, and responsibly manages resources.
Implement a culture of continuous improvement and ensure the adoption of best practices.
Ensure safety is integral to all activities.