Jabil · 1 day ago
Validation Manager
Cockeysville, MD
Full-time
Onsite
Director/Executive
$103K/yr - $186K/yr
15+ years expJabil is a leading company in the pharmaceutical and medical device manufacturing sector, and they are seeking a Validation Manager to lead all validation activities across their operations. The role focuses on ensuring compliance with global regulatory requirements and maintaining a state of control within sterile/aseptic manufacturing environments.
ElectronicsHardwareManufacturing
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 schedules in 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 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
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
Qualification
Required
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 cGMP's
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
Bachelor's degree in Science or Engineering
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
Preferred
Master's degree preferred
Audit experience is strongly preferred
Experience with Process Validation as a plus
Benefits
Medical, dental, and vision insurance plans
Paid time off
Paid parental leave
Company-paid holidays subject to change yearly
401(k) retirement plan
Employee stock purchase plan
Company
Jabil
Jabil is a product solutions company providing comprehensive design, manufacturing, supply chain and product management services.
10001+ employees
H1B Sponsorship
Jabil has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (53)
2024 (32)
2023 (40)
2022 (71)
2021 (39)
2020 (60)
Funding
Current Stage
Public CompanyTotal Funding
$4.2B2026-01-15Post Ipo Debt· $1B
2025-06-18Post Ipo Debt· $3.2B
1993-05-07IPO
Leadership Team
Steve Borges
EVP/CEO Jabil Heal
Sherman Tang
CTO, Compute and Storage
Recent News
The Motley Fool
2026-01-16
Think Business
2026-01-11
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