MES Engineer, MSAT

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

The Manufacturing Execution Systems (MES) Engineer, MSAT has responsibility for designing, validating, and implementing Electronic Batch Record (EBR) solutions for MESs to support manufacturing operations. EBRs serve to document GXP activities performed throughout the manufacturing process and integrate with other MES systems, making EBR design a core component of operations. This role will primarily focus on implementing EBR solutions using the MES platform PAS-X. The MES Engineer will be one member of a MES design team, where collaboration between Manufacturing, Engineering, Digital, Quality, and Validation is required to identify, design, and implement solutions within PAS-X in accordance with timeline objectives. The MES Engineer is the technical expert responsible for implementing user requirements, advising technical solutions, and completing Computer System Validation (CSV) activities within the MES software development lifecycle (SDLC) to migrate solutions to the production environment.

Job Responsibilities

Responsibilities include providing technical leadership for EBR design on new or existing production lines, collaborating closely with Manufacturing, Engineering, Automation, and Digital teams to ensure seamless integration.

• Provide technical leadership for MES & EBR design on new or existing production lines, collaborating closely with Manufacturing, Engineering, Automation, and Digital teams to ensure seamless integration.

• Drive EBR design, testing, and CSV within the SDLC lifecycle in coordination with manufacturing development requests.

• Develop a deep understanding of the deployed Generic Master Batch Record (GMBR) solutions.

• Self-management to keep projects on track and timeline for completion.

• Generate a variety of SDLC lifecycle documentation including CSV IQ/OQ/PQ scripting protocols and reports.

• Collaborate and build relationships with manufacturing groups to ensure development needs have been clearly met.

• Partner, refine, and implement design best practice standards.

• Develop and provide training to operations personnel based on implementation scope.

• Provide ongoing technical support and knowledge sharing to operations and engineering groups related to GMBR design and usage.

Education, Qualifications, Skills, and Experience

Minimum Requirements

• Course level or basic programming experience.

• Strong technical skills. Excellent analytical, problem-solving, and communication skills.

• Ability to work independently and manage multiple activities simultaneously.

Preferred Background

• 2+ years of experience focused on automation or software development related to processes and equipment in a manufacturing environment.

• Bachelor's degree in engineering or technical field.

• Proficiency with MES design utilizing platforms such as PAS-X.

• Experience working in a cGMP and/or regulated environment.

• Experience with process validation and project management.

• Understanding and experience with various programming languages and the software development lifecycle.

• Uses their insight to challenge and adapt current approaches and ways or working.

• Builder mentality that seeks to produce innovation, agility, and velocity to support business-as-usual operations and new project implementation.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.