Sr. MES Engineer I, San Rafael

Title: Sr. MES Engineer I

Location: Novato, CA

Job Type: FTE/Permanent

Shift Details: Standard weekday shifts, roughly 8am to 5pm with a flexible lunch time.

Flexible work from home days

Hybrid, two days per week on-site in Novato, CA.

Summary:

The Sr. MES Engineer I is responsible for the development and delivery of MES master batch records and master data required for system implementation. They support MES (Client-X) in areas including user requirements, configuration, master batch record design, application lifecycle management, system documentation, and continuous improvement. This role provides leadership and direction for MES implementation and plays a key role in decision-making for deploying Client-X across manufacturing facilities.

Responsibilities:

Work with the MES project implementation team to deliver system recipes and master data aligned with the project plan.

Provide on-call support following MES launch to production.

Participate in the development and maintenance of MES recipe GMP approval lifecycle documentation.

Contribute to process flow discussions and translate existing functionality to future state processes.

Create and maintain MES recipes and master data.

Provide MES system and recipe support across departments per defined escalation processes.

Create and maintain GMP procedures for MES recipes and master data lifecycle.

Support new process transfers and equipment process changes.

Assist in MES training for SMEs and users.

Manage MES master data change requests and provide coaching and support.

Liaise with key stakeholders to incorporate business requirements into MES.

Participate in change control programs for qualified systems.

Provide guidance, mentoring, and best practice development for MES system governance.

Apply cost-benefit thinking and global implications in decision-making.

Other duties as assigned.

Experience

Required Skills:

Minimum of 10 years experience in automation or equivalent type of process controls.

Minimum 10 years experience in Bio-Pharmaceutical or equivalent type of life science industry.

Minimum of 5 years experience with Korber Client-X MES Suite.

Experience with system implementation and SDLC requirements.

Demonstrated strengths with trouble-shooting and resolution of technical issues and challenges.

Must possess understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 requirements.

Proficiency with MS Office applications (Word, Excel, Visio, Project, Power Point).

Experience with Client ALM or equivalent software testing/requirements tools.

Good verbal and written communication skills.

Good organizational skills.

Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination.

Desired Skills:

Experience with computer validation and enterprise software deployment.

Familiarity with Mettler Toledo LabX and Aveva OSIsoft PI Historian.

Knowledge of project and GxP change control procedures, including impact assessments.

Demonstrated leadership in GxP software deployment.

Education:

B.S. in Mechanical, Electrical, Computer, or Chemical Engineering (or equivalent work experience).