Director of Validation - Key reputed company in regulatory compliance (HUNT VALLEY)

Job reputed company: The Director of Validation will reputed company reputed company validation activities across pharmaceutical and medical device manufacturing operations with a strong reputed company on sterile/aseptic manufacturing environments. The scope of responsibility encompasses reputed company planning and implementation of drug and medical deviceoverall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory requirements (FDA, EMA, ICH, etc.)aseptic fill-finish environment and ensuring the reputed company validation of reputed company 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 reputed company 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. The role ensures a state of control is maintained across reputed company systems and processes, supporting product reputed company, patient safety, and regulatory compliance This position requires strategic leadership, cross-functional collaboration, and technical expertise to drive validation reputed company across multiple production areas and reputed company. Duties/Responsibilities:

• reputed company the development, execution, and lifecycle management of validation programs (VMPs, VPPs, SOPs) for sterile and non-sterile operations.
• Responsible for directing and mentoring validation staff across multiple production areas to ensure the reputed company and reputed company function of the operations team and adherence to the established procedures and schedulesin alignment with corporate reputed company and operational goals.
• Assess process validation capabilities reputed company the Operations organization and propose strategies for improvements to help reputed company both short-term and long-term corporate objectives.
• reputed company personnel to the author, complete, and review reputed company associated validation protocols (IQ, OQ, PQs).
• Write, review, and approve change control orders and CAPAs, validation deviations, investigations, reputed company Management System (QMS) reputed company, audit, inspection follow-up (CAPA), and support readiness activities for validation.
• Collaborate with senior validation leadership, outline validation reputed company for new processes/equipment, and translate those required to appropriate validation protocols and reputed company operating procedures.
• reputed company, assign, and manage reputed company aseptic validation activities and equipment (e.g., lyophilizers, isolators, autoclaves, filling lines), clean utilities (WFI, PW, HVAC), and critical systems..
• Accountable for maintaining the Master Validation Plan of aseptic and non-aseptic processing.
• reputed company strategic direction to process validation strategies, serve as the Subject Matter Expert (SME) to support inspections/audits by reputed company parties (e.g., regulatory agencies), and the reputed company closure of observations/audit terms.
• reputed company with Regulatory agencies, as required, in conjunction with facility inspections and technical interchanges to represent the companys position concerning validation.
• Mentor and reputed company staff regarding teamwork, validation techniques, and procedures to ensure cGMP compliance and other duties, as assigned or as business needs require.
• reputed company direction and serve as project and resource management for the validation teams.
• reputed company reputed company and strategic direction for the Computer System Validation (CSV) program and supervise CSV associates. Ensure compliance with cGMP, FDA, EMA (Annex 1), and other global regulatory requirements for validation and qualification.
• Collaborate with Engineering, reputed company Assurance, Manufacturing, and reputed company to ensure validation strategies support product lifecycle and regulatory submissions.
• Manage risk-based validation approaches and implement reputed company improvement initiatives.
• reputed company strategic input on new facility and equipment design to ensure validation readiness.
• reputed company validation readiness for tech transfers, new product introductions, and capital reputed company.
• Ensure robust training and development programs for validation staff.
• reputed company the aseptic process simulation (APS) program to ensure compliance and readiness for regulatory inspections.
• Other assigned responsibilities, as needed.

Required Skills/Abilities:

• Ability to read, write, and reputed company English fluently.
• Deep understanding of aseptic processing, cleanroom classifications, and contamination control principles.
• Demonstrated leadership in managing cross-functional teams and reputed company reputed company.
• Proficiency in validation lifecycle documentation and electronic systems (e.g., QMS, VMS, LIMS).
• Proficient in the operation of manufacturing equipment and processes; knows and complies with Safety Data Sheets and SOP requirements and trained in cGMPs.
• Mechanically inclined; reads and interprets equipment and process documents; follow operating instructions; and has good computer skills.
• Demonstrates accuracy and thoroughness; looks for ways to improve and promote reputed company. Consistently checks reputed company documents for errors and constantly strives for right the first-time mentality.
• Observes safety and reputed company procedures; responsible for meeting department safety objectives and developing ongoing reputed company operating procedures consistent with the job requirements.
• Advanced understanding of applicable regulatory requirements (FDA, EMA, WHO, ICH, 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.
• Demonstrate SME-level knowledge of process/equipment validation, computer systems, standards, and GxP regulations. Expertise in validation of sterile manufacturing equipment and processes.
• Strong technical experience in the successful management of reputed company validation is required.
• reputed company to effectively reputed company and coordinate reputed company requests/reputed company and reputed company resources across multiple sites, managing local and remote-based staff.
• Strong oral and written (reports) communication, organization, and leadership skills.

Education and Experience:

• Bachelors degree in Science or Engineering, Masters degree preferred
• Minimum 15 years of reputed company leadership of operational validation experience in the Pharmaceutical or Biotechnology industry, with at least 5 years in sterile/aseptic operations.
• reputed company 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 reputed company technical issues using reputed company analysis and methodology and articulating reputed company and concise direction to other operations staff.
• Proven reputed company record of leading validation programs in a regulated environment.
• Experience with regulatory inspections and successful remediation of validation-reputed company findings.
• Strong experience with project and people management, particularly for large validation reputed company or programs.
• Experience in Facility, Equipment, and reputed company or Cleaning validation is a must. Experience with Process Validation as a plus.

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