At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the worlds top brands offering comprehensive engineering manufacturing and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

Job Summary:

The Director of Validation will lead all validation activities across pharmaceutical and medical device manufacturing operations with a strong focus on sterile/aseptic manufacturing environments. The scope of responsibility encompasses all 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 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. The role ensures a state of control is maintained across all systems and processes supporting product quality patient safety and regulatory compliance

This position requires strategic leadership cross-functional collaboration and technical expertise to drive validation excellence across multiple production areas and projects.

Duties/Responsibilities:

• Lead 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 proper and continuous function of the operations team and adherence to the established procedures and schedulesin alignment with corporate quality and operational goals.

• 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 (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.
• Provide strategic direction to process validation strategies serve as the Subject Matter Expert (SME) to 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 companys 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.
• Provide oversight 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 Quality Assurance Manufacturing and Client to ensure validation strategies support product lifecycle and regulatory submissions.
• Manage risk-based validation approaches and implement continuous improvement initiatives.
• Provide strategic input on new facility and equipment design to ensure validation readiness.
• Lead validation readiness for tech transfers new product introductions and capital projects.
• Ensure robust training and development programs for validation staff.
• Oversee 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 speak English fluently.
• Deep understanding of aseptic processing cleanroom classifications and contamination control principles.
• Demonstrated leadership in managing cross-functional teams and complex projects.
• 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 quality. Consistently checks all documents for errors and constantly strives for right the first-time mentality.
• Observes safety and security procedures; responsible for meeting department safety objectives and developing ongoing safe 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 complex validation is required.
• Able to effectively lead and coordinate complex requests/projects and allocate 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 progressive leadership of operational validation experience in the Pharmaceutical or Biotechnology industry with at least 5 years in sterile/aseptic operations.

• 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.
• Proven track record of leading validation programs in a regulated environment.
• Experience with regulatory inspections and successful remediation of validation-related findings.
• 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.

Physical Requirements:

• Must be able to walk or move or drive between locations.
• Ability to travel approximately 10% between sites.
• Ability to gown and work in an ISO-5/7 cleanroom environment.
• Ability to sit stand climb stairs and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• All job requirements in the job description provided

The pay range for this role is $103100 - $185600. Job-related non-discriminatory factors used to determine the actual offered rate include qualifications and experience geographic location education external market data and consideration of internal equity.

As part of the total rewards package Jabil offers benefits to enhance your health wealth and resilient self. These include medical dental and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly;401(k) retirement plan; and employee stock purchase plan.

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Jabil including its subsidiaries is an equal opportunity employer and considers qualified applicants for employment without regard to race color religion national origin sex sexual orientation gender identity age disability genetic information veteran status or any other characteristic protected by law.

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