Manufacturing Execution Systems (MES) Validation Analyst - onsite

Overview
We are seeking a detail-oriented and highly skilled Manufacturing Execution Systems (MES) Validation Analyst to join our team. This role is vital in ensuring the integrity, compliance, and optimal performance of MES systems within our manufacturing operations. The ideal candidate will have a strong background in Computerized System Validation processes including FDA CFR 21 Part 11, EU Annex 11, and other regulatory requirements. This candidate must posses hands on Validation experience working with MES platforms as Siemens Opscenter, Werun Pas-x, Rockwell or other such MES platforms.

Responsibilities

• Develop validation documentation such as validation plans, functional design specifications, test protocols, and standard operation procedures for computerized systems used in GMP environment.
• Review and update user requirements and functional specifications.
• Responsible for planning, scheduling, and leading validation assignments. Must demonstrate competent and effective planning, coordination, and organizational skills.
• Collaborate with cross-functional teams including Quality Assurance, Manufacturing, and IT to ensure MES system compliance and performance.
• Maintain comprehensive validation documentation, including risk assessments, validation plans, test scripts, and reports.
• Execute protocols, write reports, interpret, and evaluate validation documents in terms of acceptability to industry standards, procedures, and regulatory requirements.
• Validate interface data transfer between integrated systems to ensure data integrity, traceability, and proper system data retrieval
• Maintain accurate validation records and documentation (including validation plans, functional specifications, protocols, and SOPs) to support compliance, audits, and inspections in GMP environments.
• Provide training and support to end-users regarding validated MES systems and associated procedures.

Qualifications

• Must have experience in pharmaceutical/biotech validation which includes the writing and executing of protocols and standard operating procedures.
• Bachelor's degree in engineering discipline required. 7+ years of related experience working knowledge of in system testing, quality assurance, or computerized system validation (CSV), testing concepts, verification, and validation techniques, defect management, and risk management Experience in manufacturing processes and control systems
• Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required. Must be considered a proficient Subject Matter Expert (SME) in all validation elements.
• Proficient in writing test cases, test scripts, and validation documentation.  Experience with test management and defect tracking tools (e.g., Jira, TestRail, HP ALM)
• Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 11) and validation lifecycle activities.
• Excellent analytical skills with attention to detail and problem-solving capabilities.
• Effective communication skills for collaboration across departments and training end-users.
• Experience with Siemens OpCetner or other MES Platforms mentioned in the Responsibilities section.
• Familiarity with both manual testing and exposure to automated testing tools is a plus.
• Experience with risk-based validation approaches.
• Integration experience to enterprise systems such as ERP, LIMS, DeltaV, OSIPI or other business-critical applications.

Pay: $60.00 - $80.00 per hour

Expected hours: 40.0 – 50.0 per week

Work Location: In person