Senior MES Consultant/ MES Lead

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior MES Consultant / MES Lead based in the United States.** The Senior MES Consultant / MES Lead will deliver Manufacturing Execution System (MES) consulting services to clients in the biotechnology and pharmaceutical industries. In this role, you will lead the design, configuration, development, implementation, and validation of manufacturing systems that support critical life sciences operations. You will collaborate with business stakeholders, vendors, and technical delivery teams to translate manufacturing requirements into effective, compliant solutions. Your work will include electronic batch records, system integrations, validation documentation, and oversight of complex MES projects. This position combines technical expertise, client relationship management, and project leadership in a collaborative consulting environment. It offers the opportunity to contribute to challenging projects, support innovative manufacturing operations, and grow professionally while working remotely with regular travel to client sites. ### Accountabilities: As Senior MES Consultant / MES Lead, you will guide the delivery of MES solutions from requirements gathering through implementation and validation, ensuring that systems meet business needs and applicable life sciences standards. Your responsibilities will include: - **Lead MES solution delivery:** Design, develop, document, configure, and implement Manufacturing Execution Systems for pharmaceutical and biotechnology manufacturing environments. - **Develop electronic batch records:** Design, author, configure, and develop Electronic Batch Records (EBRs) to support the control, execution, and recording of manufacturing activities. - **Integrate manufacturing systems:** Implement MES solutions and coordinate integrations with Enterprise Resource Planning (ERP) platforms and manufacturing control equipment. - **Manage documentation and validation:** Document MES configurations and validate electronic batch records and related system functionality in accordance with applicable requirements. - **Oversee complex technical initiatives:** Provide organizational and technical oversight for projects involving MES development, configuration, and implementation. - **Gather and analyze requirements:** Work with business leaders, manufacturing users, and other stakeholders to understand operational needs and translate them into practical, value-driven technical solutions. - **Collaborate with clients and delivery teams:** Partner with customers, vendors, and internal teams to evaluate options, resolve challenges, and deliver appropriate solutions. - **Lead project teams:** Direct team activities, coordinate contributors, and manage small to medium-sized teams or projects to ensure effective execution. - **Manage client relationships:** Maintain strong client partnerships through clear communication, dependable delivery, and a customer-focused approach. - **Facilitate project meetings:** Organize discussions, align stakeholders, document decisions, and follow up on agreed action items. - **Apply analytical problem-solving:** Evaluate technical and business information, identify issues, and make sound decisions throughout project delivery. - **Support application development and validation:** Depending on project requirements, contribute to development or validation activities for a mobile application used in operational environments. **Requirements:** The ideal candidate brings substantial experience in highly automated pharmaceutical or biotechnology manufacturing, strong MES expertise, and a thorough understanding of regulated life sciences environments. You should be comfortable leading technical work, managing client relationships, and collaborating across multidisciplinary teams. Required qualifications include: - **Education:** Bachelor's degree in science, engineering, or a related technical discipline. - **Industry experience:** At least 5 years of experience in a highly automated pharmaceutical or biotechnology manufacturing environment. - **MES platform expertise:** Hands-on experience with Syncade, POMSnet, PAS-X, Camstar, or another MES platform suitable for the life sciences industry. - **Regulatory knowledge:** Strong knowledge of FDA requirements and Good Manufacturing Practice (GMP) guidelines. - **Software lifecycle expertise:** Working knowledge of Software Development Life Cycle (SDLC) practices and software support methodologies. - **Validation experience:** Understanding of validation processes within regulated life sciences environments. - **Communication skills:** Excellent written and verbal communication skills, with the ability to explain technical concepts and collaborate effectively with clients and colleagues. - **Leadership and teamwork:** Ability to guide project teams, coordinate stakeholders, and contribute effectively in a collaborative, team-oriented environment. - **Meeting facilitation:** Experience facilitating meetings, documenting outcomes, and ensuring action items are completed. - **Client service and integrity:** A strong customer-service mindset, professional integrity, a dependable work ethic, and the ability to build trusted relationships. - **Analytical thinking:** Strong problem-solving skills and the ability to assess information accurately and make sound decisions. - **Adaptability:** Ability to learn new technologies, skills, and multidisciplinary concepts quickly. - **Location eligibility:** Must reside in the United States or Canada. - **Travel availability:** Willingness to travel to client sites as required, with travel typically averaging approximately 25%–65%, depending on project and customer needs. **Benefits:** - **Full-time opportunity:** Work on consulting projects supporting pharmaceutical and biotechnology manufacturing operations. - **Remote work:** Primarily remote work, with travel to customer sites based on project requirements. - **Career advancement:** Opportunities for professional development and career growth. - **Challenging projects:** Exposure to complex MES implementations, electronic batch records, system integrations, and validation initiatives. - **Collaborative environment:** Work alongside clients, vendors, and multidisciplinary delivery teams. - **Leadership opportunities:** Lead technical activities, coordinate project teams, and manage small to medium-sized projects. - **Employee benefits:** Access to a benefits package; specific benefit details were not provided in the original job description.