Career Opportunities

Associate Director, Validation

Description of Duties:

• Responsible for directing and scheduling validation activities. Duties include writing, approving and executing protocols, preparing final reports and performing periodic reviews.
• Responsible for directing all Validation activities to include process equipment, analytical instrumentation, utilities and facilities, cleaning and process validation, automation systems, computer systems, and supportive services.
• Responsible for developing and maintaining a comprehensive Master Validation Plan to identify equipment and processes that require validation.
• Develop validation acceptance criteria and provide necessary in-house training for validation activities.
• Provide support for automated control system validations as required using GAMP5 and ASTM E2500 methods.
• Utilize available industry information and internal tools (i.e., internal and external audit findings, EMEA &FDA observations, failure investigations) to identify validation program deficiencies. Recommend and implement changes to meet regulatory requirements.
• Coordinate with other area departments to perform risk and gap analyses of targeted processes, locate the areas of improvement opportunity, execute on the identified action items and sustain the results.
• Responsible for the leadership and management of the validation department activities, including budgeting and budget compliance.
• Estimate validation resources and costs based on project needs.
• Act as the communication interface with quality management relating to validation information and status.
• Supervise/train staff and oversee contract personnel on validation program, processes, and initiatives
• Provide departmental management with periodic updates concerning the status of validation initiatives

Job Qualifications:

• BS/MS in Engineering or Life Science
• 8-10+ years experience working in the pharmaceutical and/or biotechnology industries, including facility, utility, process, equipment and automation/ computer validation experience
• Excellent working knowledge of cGMPs as they relate to the role of computers in manufacturing and laboratory operations. Knowledge of 21CFR Part 11 requirements.
• Knowledge and experience with process, utility and equipment validation, sterilization and cleaning validation.
• Working knowledge of cGMP and validation requirements, as well as experience in the development and execution of validation and qualification protocols and preparation of associated reports.
• The ability to analyze data using basic statistical methods.
• Strong leadership, team-building, interpersonal and written/verbal communication skills.