Validation Manager

Location: Hunt Valley

This job is with Jabil, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's 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 Validation Manager 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 device overall 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 Manager will also schedule the appropriate resources for assistance with validation, to meet the established production schedule, vendor/contract activities in the clean rooms, 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 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…