Sr MES PharmaSuite Consultant

Client is seeking a highly experienced and resilient Senior Pharma Suite Owner's Representative to join our client's critical automation system replacement project in their state-of-the-art biopharmaceutical manufacturing facility. This individual will act as a key liaison, advocating for the client's best interests and ensuring the successful implementation of the Rockwell PharmaSuite MES. This is a demanding, long-term contract role requiring a professional who thrives in a high-pressure environment and possesses exceptional technical and interpersonal skills.

Key Responsibilities

• Serve as a dedicated owner's representative, safeguarding the client's interests throughout the implementation of the Rockwell PharmaSuite MES.
• Act as a subject matter expert (SME) in Rockwell PharmaSuite, providing guidance and oversight to internal teams and external system integrators.
• Hold external vendors and system integrators accountable for their deliverables, timelines, and adherence to project scope, ensuring high-quality execution and functional equivalency.
• Collaborate closely with the client's project team, integrating seamlessly into their daily operations and decision-making processes.
• Monitor project progress, identify potential risks and issues related to Pharma Suite implementation, and proactively work towards solutions.
• Ensure all PharmaSuite activities align with GXP regulations, 21 CFR Part 11 compliance, and other relevant pharmaceutical industry standards.
• Contribute to the successful transition from the legacy Honeywell Experion/PMS/MES system to the new Rockwell PharmaSuite stack.
• Be prepared for an intensive work schedule, including significant overtime and potential work during holidays, to meet aggressive project timelines.
• Maintain a strong, professional demeanor under pressure, demonstrate adaptability, and effectively manage feedback.

Qualifications

• Minimum of 10+ years of hands-on experience with Rockwell PharmaSuite implementation, configuration, and support in a pharmaceutical or life sciences manufacturing environment.
• Proven experience acting as an owner's agent, owner's representative, or client liaison on large-scale automation or MES projects, demonstrating the ability to hold vendors accountable.
• Deep understanding of GXP regulations, FDA compliance (e.g., 21 CFR Part 11), and pharmaceutical manufacturing processes.
• Strong knowledge of Rockwell Automation technologies, including PlantPax and ControlLogix, is highly desirable.
• Exceptional problem-solving skills and the ability to operate effectively in a fast-paced, complex, and demanding project environment.
• Excellent communication, interpersonal, and negotiation skills, with the ability to effectively communicate technical information to both technical and non-technical stakeholders.
• Demonstrated ability to work autonomously and collaboratively within a large project team.
• Prior experience with the client's CCP2 facility is a plus.
• A "salt of the earth" mindset, capable of taking criticism and adapting quickly without becoming aggressive or resistant.

Project Details

• Duration: Long-term, expected through January 2028 (with potential for immediate start for the right candidate).
• Work Environment: High-pressure, fast-paced, and demanding, requiring significant dedication and flexibility.