Manufacturing Operations Specialist

Location and Employment Details

This Manufacturing Operations Specialist position is located in Waterford, Ireland, within Sanofi's biopharmaceutical and medical device campus. It is a fixed-term contract lasting 23 months, with full-time, day-shift hours on site.

About Sanofi Waterford

The Waterford site has been growing for over 20 years and employs nearly 800 people. The campus is state-of-the-art and recognized through several awards. Employees benefit from flexible working arrangements, career growth opportunities in a single location, and facilities such as an onsite gym and medical center that emphasize health and wellness.

Role Overview

The Manufacturing Operations Specialist applies expertise in Quality Management Systems (QMS), compliance, and GxP manufacturing processes to lead investigations and continuous improvement initiatives within manufacturing operations.

Key Responsibilities

• Collaborate with the Manufacturing team to ensure production, storage, and packaging meet current Good Manufacturing Practice (cGMP) standards.
• Promote and adhere to Sanofi's safety procedures by practicing safe work habits.
• Support cross-functional teams by driving investigation closures, identifying root causes, and implementing corrective and preventive actions (CAPA).
• Use manufacturing process knowledge and investigative skills to resolve issues, enhance process operations, and facilitate positive change.
• Manage document revisions, including batch production records, manufacturing procedures, and related cross-functional documents.
• Work closely with Team Leaders and managers to develop and maintain staff training materials and curricula concerning process operations, theory, and compliance.
• Provide on-the-floor training to staff as needed and assist in developing GMP training packages.
• Participate in preparing and reviewing procedures and batch documentation.
• Conduct audits in all areas according to the defined schedule.
• Ensure effective implementation and maintenance of Sanofi’s quality system and compliance with cGMP requirements.
• Proactively identify opportunities for continuous improvement (CI) projects and support manufacturing-related projects as required.

Essential Qualifications

• Experience working in a cGMP manufacturing environment is mandatory.
• Previous experience in sterile manufacturing is preferred but not essential.

Desirable Skills and Expertise

• Proficiency in operating, cleaning, and maintaining manufacturing equipment.
• Familiarity with MES (Manufacturing Execution Systems), SCADA, and SAP systems.
• Strong problem-solving and analytical abilities.
• Good understanding of mechanical operations.
• Technical writing capabilities.
• Solid knowledge of cGMP principles.
• Excellent interpersonal communication skills.
• Awareness of site Key Performance Indicators (KPIs).

Sanofi Commitment

Sanofi is committed to progress and innovation with a diverse workforce united to create better medications and outcomes. The company provides equal employment opportunities regardless of race, color, ancestry, religion, gender, sexual orientation, age, citizenship, marital status, ability, or gender identity.