Process Specialist - MES (API Manufacturing)

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development empowering our team members to grow personally and professionally.

Position Overview

We are seeking a skilled and detail-oriented Process Specialist with hands-on experience in Active Pharmaceutical Ingredient (API) chemical synthesis processes and a solid understanding of Manufacturing Execution Systems (MES). The ideal candidate will serve as a process subject matter expert (SME) supporting digital and operational initiatives, ensuring that manufacturing workflows, batch execution logic, and documentation accurately reflect real shopfloor practices. 

This role focuses on process understanding, operational flow, GMP compliance, and manufacturing alignment, acting as the bridge between process engineering, production teams, and digital manufacturing systems.

Key Responsibilities

• Review and evaluate manufacturing workflows, batch processes, and operational sequences to ensure alignment with actual API production practices.
• Act as the process subject matter expert (SME) for API manufacturing in design workshops, collaborating with MES engineers, system integrators, and end users.
• Provide process expertise during the development and review of Master Batch Records (MBRs) and Parameter Value Lists (PVLs), ensuring they accurately reflect process steps, critical parameters, material flows, and equipment usage.
• Validate that proposed digital workflows correctly represent Shopfloor operations, Equipment interactions, Critical process parameters (CPPs), and material movements and reconciliation. 
• Participate in cross-functional reviews with Manufacturing, MSAT, CQV, Quality, and Engineering teams to ensure process integrity is maintained throughout system implementation.
• Identify and escalate process-related risks, potential GMP gaps, or operational mismatches within manufacturing workflows.
• Support deviation investigations, change controls, and continuous improvement initiatives from a process impact perspective.
• Ensure all process documentation and system-supported workflows comply with GMP and data integrity requirements.

Required Qualifications

• Bachelors degree in Chemical Engineering, Life Sciences, or related field.
• Strong hands-on experience with API manufacturing processes, including understanding of process steps, critical parameters, and typical plant operations.
• Prior involvement in MES implementation or system validation projects (e.g., PAS-X, Siemens Opcenter) is highly preferred.
• Ability to independently assess MES design documents and provide process-aligned feedback.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.