Lead MES Engineer at Azzur Group in Devens, Massachusetts

Job Description:

As an MES Engineer at Azzur Group you will play a pivotal role in the implementation, validation, and support of Manufacturing Execution Systems (MES), particularly the Emerson Syncade system. You will work closely with clients to understand their manufacturing processes and configure MES solutions to optimize efficiency and compliance with regulatory standards.

Key Responsibilities:

• Lead the implementation and configuration of Emerson Syncade manufacturing execution systems for clients in various industries.

• Collaborate with clients to understand their manufacturing processes and translate requirements into MES solutions that streamline operations and ensure compliance with regulatory standards.

• Develop and execute validation protocols for MES implementations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Configure Syncade workflows, electronic batch records, and other MES functionalities to meet client specifications and enhance process efficiency.

• Provide technical expertise and support to clients during MES system upgrades, expansions, and troubleshooting activities.

• Collaborate with project managers and cross-functional teams to ensure alignment of MES implementation and validation activities with project timelines and objectives.

• Stay current with industry trends, regulatory guidelines, and advancements in MES technology to continuously improve implementation and validation processes.

Qualifications:

• Bachelor's degree in Engineering, Computer Science, or related field. Master's degree preferred.

• Minimum of 5 years of experience in implementing and validating Manufacturing Execution Systems, with proficiency in Emerson Syncade preferred.

• Strong understanding of manufacturing processes and regulatory requirements (e.g., FDA regulations, GAMP 5) related to MES implementations.

• Experience with configuring MES functionalities such as electronic batch records, workflows, and data interfaces.

• Excellent analytical and problem-solving skills, with the ability to optimize manufacturing processes through MES solutions.

• Effective communication skills, both verbal and written, with the ability to interact professionally with clients and team members.

• Detail-oriented mindset with a commitment to producing high-quality MES configurations and validation documentation.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values.

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