Inspection and Packaging Operator Senior (Lead)

Inspection/Packaging Operator Senior (Lead)
Job Overview
This position is responsible for performing routine tasks, operating state-of-the-art equipment, and troubleshooting in the areas of Syringe Inspection, Syringe Packaging, Vial Inspection and Vial Packaging at PVT and Bell Drive packaging Lines. This position is also responsible for providing guidance and instructions to less experienced Operators, coordinate daily production activities within the packaging area, and performing/coordinating activities such as component staging, training, break relief, SAP transactions, Batch Record Review and controlled document revision. This position supports execution of the production plan and acts as a role model for less experienced members.
Responsibilities

• Operate and troubleshoot high-speed automated Inspection and Packaging equipment. Typical tasks include loading vials/syringes onto automated inspection equipment, changing label reels, replenishing packaging items (e.g. inserts, labels, cartons, trays, shippers), operating syringe assembly machine, Thermoformers, cartoner, case palletizer, serialization equipment, and wrapping pallets.
• Participate in line changeovers and continuously strive to minimize line downtime and maximize OEE%.
• Perform batch record reviews, logbook reviews, and SAP transactions.
• Perform OJT (On-the-job) training of less experienced Operator and ensure compliance with cGMPs and SOPs.
• Perform routine Quality and Safety inspection walk-throughs of the production areas.
• Schedule and coordinate periodic cleanings of equipment and Packaging rooms.
• Will serve as witness of routine unit operation tasks for batch record signing. Maintains all associated documentation for operations being performed.
• Will be assigned formal FMEAs, RAs, CAPAs, CCRs and NCRs as needed.
• Implements and maintains production schedules based upon intra-departmental information.
• Generally, receives minimal instructions on all assignments with some supervision. Takes initiative to identify issues, troubleshoot, propose solutions, and keep management informed.
• Other duties may be assigned as required.
• Batch Records and SOPs updates.
• Ensure eOEE entries are accurately complete at the end of production shift.
• Participate and drive daily Level 1 +QDCI meetings with team members.

Basic Qualifications:

• High School Diploma or GED and 8-10 years experience required or
• AA degree in science, engineering, or a related discipline and 6-8 years experience.
• BS degree science, engineering, or a related discipline and 3-6 years experience.

Preferred Qualifications:

• Prior mechanical experience and/or experience working as a Lead Packaging Operator in Pharmaceutical or Medical device industries.
• Engineering background.
• Experience working with Inspection, Packaging and Serialization equipment.
• Lean and/or Six Sigma certification

Terms of employment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job, majority of the work activities are performed while standing.

• Ability to stand over intervals of several hours at a time
• Ability to bend, squat, and reach
• Ability to lift, push or pull various amounts of weight
• Ability to pass the required visual acuity test (wearing corrective lenses if needed)

Based on production demands and personnel availability, different start time scenarios or additional hours may be required so a flexible work schedule is required for the candidate. Core Work hours for the available shifts may differ based on production needs.
Benefits of working in this role

• This position wears many "hats" and requires frequent interaction with other departments. This helps to facilitate career growth.
• Work with state-of-the-art Inspection and Packaging technologies.
• Be part of a team that strives to meet and exceed all production, quality, and safety expectations.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.