Job Description

Job Description

Job Description

Job Overview:

The Director of Validation will lead pharmaceutical and medical device validation operations and staff across all company sites. The scope of responsibility encompasses all planning and implementation of drug and medical device overall validation activities, including computer systems in an aseptic fill-finish environment and ensuring the proper validation of all equipment and processes. The Validation Director will also schedule the appropriate resources for assistance with validation, to meet the established production schedule, vendor/contract activities in the cleanrooms, maintain a state of control within the cleanroom environment, and support facilities and other operations, development, and maintenance of validation program documents including SOPs, Validation Project (VPP) and Validation Master (VMP) Plans. This individual should manage tasks and responsibilities with minimal guidance and demonstrate outstanding multi-tasking, problem-solving, and communication skills in a dynamic and challenging contract manufacturing environment.

Responsibilities:

• and adherence to the established procedures and schedules.
• Assess process validation capabilities within the Operations organization and propose strategies for improvements to help achieve both short-term and long-term corporate objectives.
• Direct personnel to the author, complete, and review all associated validation protocols (IQ, OQ, PQs).
• Write, review, and approve change control orders and CAPAs, validation deviations, investigations, Quality Management System (QMS) oversight, audit, inspection follow-up (CAPA), and support readiness activities for validation.
• Collaborate with senior validation leadership, outline validation strategy for new processes/equipment, and translate those required to appropriate validation protocols and standard operating procedures.
• Oversee, assign, and manage all aseptic validation activities and equipment.
• Develop, author, review, and/or approve all drug and medical device validation protocols.
• Accountable for maintaining Master Validation Plan of aseptic and non-aseptic processing.
• Interact with clients for assigned aseptic validation projects.
• Provide strategic direction to process validation strategies, support inspections/audits by third parties (e.g., regulatory agencies), and the timely closure of observations/audit terms.
• Interface with Regulatory agencies, as required, in conjunction with facility inspections and technical interchanges to represent the company’s position concerning validation.
• Mentor and develop staff regarding teamwork, validation techniques, and procedures to ensure cGMP compliance and other duties, as assigned or as business needs require.
• Provide direction and serve as project and resource management for the validation teams.
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree in science or engineering, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Master’s degree is preferred.
• 15 years of progressive leadership of operational validation experience in the Pharmaceutical or Biotechnology industry
• Sound industry knowledge of pharmaceutical and medical device facilities, lyophilization technology, cleanrooms, facilities clean utilities. WFI, purified water, process gasses, HVAC, and industrial processes and utilities.
• Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff.
• Strong experience with project and people management, particularly for large validation projects or programs.
• Experience in Facility, Equipment, and Utility or Cleaning validation is a must. Experience with Process Validation as a plus.
• Demonstrate SME-level knowledge of process/equipment validation, computer systems, standards, and GxP regulations. Strong technical experience in the successful management of complex validation is required.
• Able to effectively lead and coordinate multiple complex requests/projects and allocate resources effectively across multiple sites, managing both local and remote-based staff.
• Advanced understanding of applicable regulatory requirements (FDA, EMA, international regulatory).
• Audit experience is strongly preferred.
• Advanced understanding of industry standards for commissioning and validation of facilities, utilities, and process equipment for cGMP manufacturing.
• Knowledge / Experience with electronic Quality Management Systems such as MasterControl
• Knowledge of current federal, local, and international regulations regarding the production, testing and release of drug substances and products.
• Demonstrated proficiency with Microsoft programs, such as Word, Excel, PowerPoint, Access, Project, etc.
• Demonstrate the ability to build and maintain good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands:

• Ability to travel approximately 10%
• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

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