Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position in a GMP manufacturing plant:

• Sr. MES Designer

Site cross-functional leader that provides direction to individual operating system owners within the North America manufacturing sites to identify opportunities assess business process impact, and support future system functionality design decision-making for MES and other applicable systems. Direct the activities for integration, design, development, documenting, testing, and implementing Manufacturing Execution Systems (MES) solutions. Provide organization oversight for complex systems involving the development of MES solutions and work closely with business management and users to define the needs and design solutions that add value to the company. Take ownership of deployment projects through the entire lifecycle from detailed planning to customer/support acceptance, interface with customers, and provide technical assistance in production issues and resolutions. Work with business leaders, process owners, team members, and system users to establish and enhance business processes with MES solutions through analysis and documentation, such as Functional Specifications and System Design Specifications. Ability to be hands-on with MES configuration and development, as required & directed by MES changes. Driving continuous improvement utilizing lean or six-sigma tools. Responsible for knowledge transfer and sustainability of optimal processes by managing a group of direct and indirect cross-functional resources.

Area Responsibilities:

• Standardizes MES for Supply Chain E2E and across all business domains.
• Educates business team members on Manufacturing Execution Systems employed globally.
• Ensures harmonization among all business units.
• Documents details of AS-IS business processes and traits of the trade.
• Supports the (SME)/(PU) network in resolving system issues.
• Analyzes and prioritizes Manufacturing Execution Systems support requests in alignment with a supervisor.
• Approves TO BE business processes in alignment with the Company's environment, requirements, and processes.
• Provides technical knowledge, expertise, and hands-on experience in the maintenance of information such as instructions, steps, material data, equipment, and processes in the Electronic Master Batch Records (MBRs) in the MES System.
• Provides technical knowledge, expertise, and hands-on experience in the maintenance of Master Data such as equipment, material data, compatibility rules, locations production units, state diagrams, and electronic Batch Records (EBR) approvals roles, among others, to support the MES system for business areas.
• Provides technical knowledge, expertise, and hands-on experience in the development oversees and / or delivers training for SOP and Master Batch Records related to the electronic batch record process.
• Assure all manufacturing processes in the MBR are aligned with the validated state.
• Assures the accurate and timely transfer and approval process of the manufacturing and / or packaging MBR to the MES System.
• Review and approve the manufacturing and packaging procedures in alignment with the MES System.
• Ensures that the goals and objectives established in action plans and projects are aligned with the goals and overall business objectives. Supports the development of business objectives, as required.
• Supports the gathering of data to develop and present metrics related to projects.
• Able to show results against execution and coordination of ongoing process improvement plans through metrics and achievement of milestones. Communicates progress to site management and others, as required
• Analyze and prioritize assigned support requests related to MBR.
• Attends and complies with applicable education and training programs and proactively identifies new training or certifications to ensure the right level of business support.
• Participates in special activities that the company promotes geared toward establishing its strategic goals.
• Complies with the company policies, procedures, and rules, as well as those of regulatory agencies, and ensures compliance with such.
• May represent Plant Systems Owner, as required.
• Performs any other duty related to the position assigned by the supervisor
• Drives continuous improvement processes and opportunities. Serve as an internal cross-functional expert and representative in chain teams.
• Supports the SME/PU network in resolving system issues.
• Analyzes and prioritizes overall site support requests.
• Leads system/process improvement initiatives through the direct and indirect organization, including formal and informal roles.
• Standardizes and leverages solutions across sites.
• Assesses and manages cross-functional impacts of proposed changes.
• Assures that security and compliance requirements are complete related to user access.
• Participates in training strategy design efforts and drives adherence.
• Participates with other application systems owners to review the cross-business impact of system-related projects.
• Supports the escalation process for power user/end-user support issues.
• Maintains current knowledge regarding quality assurance/quality control techniques, as well as the technology of the company’s products and processes.
• Participates actively in regulatory agency audits.
• Supports and actively participates in internal and external committees related to business issues.

Education: Bachelor’s degree in Engineering, Science, Business Administration, or a related field from an accredited college or university.

Experience: Three to Five years of managerial experience. Project management experience with impact on multiple functional groups within a manufacturing location. Two to Three years of responsibility and experience in a GMP product manufacturing plant environment. Broad working knowledge of the pharmaceutical drug product operating functions of quality and compliance, material supply, material handling and control, product manufacturing, and packaging.

Knowledge, Skills, and Abilities: Bilingual (English and Spanish) with excellent verbal, writing, and technical writing skills in both languages. Ability to interpret and apply current Good Manufacturing Practices. Mathematics skills and analytical ability. Basic skills in SAP inventory system transactions. Knowledge and skills in validation processes and statistical process control, detection, correction and error prevention, process system challenges, knowledge of sampling process, audits, root cause analysis, and risk management. Basic computer knowledge (Microsoft Office software - Excel, PowerPoint, Word). Must be able to make decisions based on available facts while meeting established deadlines and priorities—demonstrated leadership. Well-versed in the latest quality assurance techniques. Able to work with minimum supervision and under pressure. Takes the initiative and makes a good judgment in the performance of duties. Ability to communicate effectively with personnel. Must have the ability to identify gaps in system capabilities. Success in this role will require strong change leadership skills to get consensus from management and end-users to adopt process and system change. This position also requires active decision-making skills. Given any environment, scenario, and situation, the responsibility is to make decisions considering the organization's best interests, the comfort of the users, and the viability of executing the decision. In addition, the position will provide production support in-plant logistics, manufacturing execution, and preventive maintenance/calibration.

Certifications/Licenses: None.

Able to travel in and outside of Puerto Rico. Able to work extra hours and respond to emergency calls that require returning to the company after regular working hours of the business. Able to support other departments and/or projects according to business needs