Job Description

Role: Consultant MES Specialist for Fermentation Unit Operations
Location: Boston, MA
Emp Type: Contract (C2C/W2)
Interview: Phone/Skype
Background check: Mandatory
Meet and great: Mandatory

We are seeking an experienced MES Specialist to support our fermentation unit operations. The ideal candidate will have a strong background in recipe authoring and experience with Electronic Batch Records (EBR). The role involves collaborating with end-users to ensure the effective implementation of the Apprentice Tempo MES, as well as creating and updating User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) documents.

Key Responsibilities:

- Recipe Authoring:
- Develop and author recipes in Apprentice Tempo MES for fermentation processes, utilizing existing Master Batch Records as a baseline.
- Ensure recipes are optimized for efficiency, quality, and compliance with regulatory standards.
- Collaborate with cross-functional teams to gather input and validate recipes.

- Testing of Electronic Batch Records:
- Work closely with end-users to test Electronic Batch Records, ensuring they meet operational requirements and align with recipe specifications.
- Facilitate user acceptance testing (UAT) sessions and gather feedback for improvements.
- Troubleshoot and resolve issues identified during testing, collaborating with IT and engineering teams as necessary.

- Documentation:
- Create and update User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) documents to reflect changes in processes or system capabilities.
- Maintain comprehensive documentation of recipe authoring processes, testing protocols, and system updates.
- Ensure all documentation adheres to company standards and regulatory requirements.

- Training and Support:
- Provide training and support to end-users on the use of Apprentice Tempo MES and Electronic Batch Records.
- Develop user guides and training materials to facilitate onboarding and ongoing education.

- Continuous Improvement:
- Participate in continuous improvement initiatives to enhance MES functionality and overall operational efficiency.
- Stay current with industry best practices, regulatory changes, and emerging technologies related to MES and fermentation processes.
§ Recipe authoring for Apprentice Tempo MES for Fermentation Unit Operations based of existing Master Batch Record
§ Work with end users to test Electronic Batch Records
§ Create and update URS/FRS documents
Strong understanding of URS/FRS documentation and best practices.
- Excellent problem-solving skills and attention to detail.
- Strong communication skills, with the ability to collaborate effectively with cross-functional teams.
- Proficiency in relevant software tools and systems used in MES and batch record management.

Additional Information:

- Work Environment:
- This role may require occasional overtime or flexible hours to accommodate project deadlines.

- Physical Requirements:
- Ability to work in a manufacturing environment, which may involve standing for extended periods and following safety protocols.

Additional Information

All your information will be kept confidential according to EEO guidelines.