Website RCM Technologies, Inc. | Life Sciences / Data & Solutions
RCM Technologies, Inc. | Life Sciences / Data & Solutions
Company : RCM Technologies, Inc. | Life Sciences / Data & Solutions
Full Time Contract
Title: MES Recipe Configuration and Validation Specialist
Compensation: Market Rate
Location: Hybrid
Length of Contract: 6-12 months
Company description:
Our client is a global pharmaceutical leader dedicated to discovering, developing, and delivering innovative medicines that make life better for people around the world. The client site plays a crucial role in manufacturing life-changing treatments, driven by a commitment to quality and patient well-being.
Position description:
RCM is looking for a highly motivated and detail-oriented MES Recipe Configuration and Validation Specialist to join our client team in Carolina, Puerto Rico. In this critical role, you will be responsible for the accurate configuration, rigorous testing, and robust validation of Manufacturing Execution System (MES) recipes, ensuring seamless and compliant pharmaceutical manufacturing operations.
Responsibilities:
Design and Configure MES Recipes: Translate complex manufacturing processes and batch records into accurate and efficient MES (e.g., Syncade, Werum Client-X, etc.) recipes, adhering to design specifications and user requirements.
Develop and Execute Validation Protocols: Generate and execute comprehensive validation protocols (e.g., IQ, OQ, PQ) for MES recipes, ensuring all configurations meet regulatory and business requirements.
Perform Recipe Testing and Troubleshooting: Conduct thorough testing of MES recipes, identify and resolve configuration errors, and troubleshoot complex system issues to ensure optimal performance.
Manage Change Control for MES Recipes: Initiate, manage, and completely change control records for all MES recipe modifications and new implementations, utilizing electronic systems (e.g., Trackwise).
Generate and Maintain Validation Documentation: Prepare and maintain comprehensive validation documentation, including test scripts, traceability matrices, summary reports, and standard operating procedures (SOPs).
Collaborate with Cross-Functional Teams: Work closely with Manufacturing, Quality Assurance, Automation, IT, and Process Development teams to define requirements, support implementation, and ensure successful recipe deployment.
Support Electronic Batch Record (EBR) Implementation: Assist in the ongoing design, testing, and maintenance of Electronic Batch Records (EBRs) and their integration with other enterprise systems (e.g., SAP ERP).
Ensure GMP Compliance: Uphold the highest standards of cGMP compliance in all MES recipe configuration, validation, and documentation activities.
Qualifications
3+ Years MES Expertise: Minimum of 3 years of experience in MES recipe configuration, development, or authoring within a pharmaceutical or biotechnology manufacturing environment.
Proven MES Validation: Demonstrated experience in MES validation, including IQ, OQ, and PQ protocol generation and execution.
MES Platform Proficiency: Proficient in at least one major MES platform (e.g., Emerson Syncade, Werum Client-X, Rockwell PharmaSuite, etc.) and a strong understanding of automation and control system interfaces with MES.
GMP & Regulatory Acumen: Solid understanding of cGMP regulations, GAMP 5 guidelines, and data integrity principles in a pharmaceutical context.
Robust Documentation Skills: Excellent technical writing and documentation skills, with proven experience developing validation protocols, reports, and Standard Operating Procedures (SOPs).
Effective Problem-Solver: Proven ability to troubleshoot complex system issues and provide effective, timely solutions.
Collaborative Communicator: Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams and convey technical information clearly.
Bilingual & Organized: Fully bilingual (English and Spanish) with strong organizational skills, detail-orientation, and a proactive approach to managing multiple priorities in a fast-paced environment.
Education
Bachelor’s degree in Engineering (Chemical, Biomedical, Industrial, Computer), Computer Science, Information Systems, or a related scientific discipline.
Equal Opportunity Statement:
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.
Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
About RCM:
RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America .