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Senior Production Technician - Formulation

Swiftwater, Pennsylvania

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Overview

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Benefits

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    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

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"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

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Suncére Hernandez Area Business Manager, Multiple Sclerosis

"Patients are at the center of our work. Our teams focus on advancing transformational therapies, and expanding patient access to our medicines."

Mouhamed Gueye US Head Medical, Rare Blood Disorders

Responsibilities

POSITION OVERVIEW

This is a 3rd shift position.

Who We Are

Sanofi Pasteur is the vaccine division of Sanofi. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is located in northeast Pennsylvania and is home to the production of over 120 million doses of vaccine each year.

The Formulation, Filling, Inspection & Packaging (FFIP) team is comprised of highly-skilled professionals who work to transform drug substances into finished products in vial or syringe presentations of the highest quality, ready for distribution around the world.

Who You Are

The senior production technician is the “heartbeat” of the Drug Product vaccine manufacturing and is primarily responsible for the high quality and efficient production of our vaccines in accordance to current good manufacturing practices (cGMP) for all relevant regulatory agencies (e.g. FDA).

What You Will Do

  • Prep area support (CIP/SIP tanks, COP parts, filter testing, etc.); Formulation skid prep (CIP/SIP)

  • SAP transactions (ordering supplies, inventory management, work orders, complete pick lists and process orders, cycle counts, schedule and confirm phases)

  • Sample management (LIMS/Labware, delivery)

  • Qualified trainer on one or more critical functions

  • General maintenance and housekeeping (chart changes, pressure checks, restocking)

  • Monitoring (daily release, environmental monitoring, WFI/CS sampling, cleaning monitoring)

  • Cross-trained to perform skid operation on multiple Formulation skids; Cross-trained on at minimum 50% or more on Formulation critical processes (Batch formulation activities, CIP and SIP of skids and tanks and EM/water sampling)

  • Completes batch record transcription and prepares batch record for manager review; manage retro-release of buffers and control of inventory and use

Safety:

  • Participates in monthly safety meetings

  • Reports all safety issues, concerns, incidents, and near-misses to leadership

  • Participates in safety audits as scheduled

  • Works with the safety and leadership team to provide input for potential safety issues as well as contributing ideas, implement all safety initiatives by actively and effectively communicating the initiatives, and by helping others to understand the initiatives.

  • Works with the safety team to ensure that the resources required addressing safety issues are secured in a timely manner and that the effective resolutions are put into place and trained upon. 

Quality:

  • Regulatory audit understanding and awareness.  Ensures effective procedures are followed at all times

  • Identifies potential deviation occurrences and prevents or aids in investigations and root cause analysis as well as corrective and preventive actions

  • Ensures completion and review of quality documentation (BPRs, logbooks, etc.) accurately and in a timely manner for process area assigned

  • Understands the function of the quality group and works with them to maintain a positive rapport

  • Identifies areas of deficiency and offers suggestions for improvements

Delivery:

  • Works to ensure preparation activities (CIP/SIP, COP, area cleaning, material staging, etc.) is completed in a timely manner to ensure production schedules are adhered to

  • Works to ensure samples are taken, documented, and delivered in a timely manner in accordance with applicable requirements (WFI/CS samples, process-related samples, EM samples, etc.)

  • Works to ensure buffer formulation processes are executed in accordance with the production schedule

  • Ensures process-related documentation is completed the right first time

  • Manages retro release of buffers including managing quarantine/expiry and control of inventory and use

Cost:

  • Works to ensure procedures are followed so as to not generate re-work

  • Participates or leads in all aspects of the production process and access required for these processes.  Examples:

    • SAP key user

    • SAP Cycle Counting

    • SAP Goods Receipt

    • SAP Bin to Bin

    • SAP Reversals

    • SAP Split and Merge

    • LIMS Labware (WARP)

    • Deviation

    • Change Control

    • HSE

    • Batch Release

    • eBuy

    • Labwatch

    • eDoc

    • Confirming phases in-process orders

  • Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions

  • Continuous monitoring of processes

  • Data tracking

  • Works to resolve common production issues related to the area of work

Involvement:

  • Works to become trained on all assigned training modules

  • Trains and orients new team members (at any level) as assigned. 

  • Participates in team meetings.  Understands respect, professionalism, and confidentiality

  • Ensures all materials required for production are available prior to the need

  • Follows proper documentation as required by cGMP

  • Has a thorough working knowledge of cGMP’s and works to help others understand

  • Ensures all areas within the department are adequately covered at all times for the current shift and upcoming shifts.

  • Qualified trainer on one or more critical processes

  • Involved in at least one cross-functional team where necessary to complete projects in an effective and timely manner

  • Seeks out cross-training in other areas within the department

  • Continues development by completing at least one developmental class annually. 

  • Performs all other duties as assigned.

Basic Qualifications:

  • HS diploma or GED and 2+ years of manufacturing experience

  • Associates with 1 + year manufacturing experience

  • Bachelors with 0 + years manufacturing experience

  • Requires good mechanical skills, computer skills and is detail-oriented.

  • Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting, and manual dexterity.

  • Prior or related cGMP or Pharmaceutical experience recommended

  • Proficiency in at least but not limited to three areas of operations or product line.

  • Must be a qualified trainer in one or more areas. Must be proficient in at least one of the following areas: BFR review, Environmental monitoring, Utlity Sampling, Documentation Coordinator, logbook review, technical writing (SWI revisions).  

  • Must have knowledge and access to systems (SAP, Phenix, Master , EMS, PMS, SCADA, RT Reports, Labware).

  • Must have knowledge and access to systems in applicable buildings and processes which have these systems (SFD, PI)

Preferred:

  • Aseptic Gown training

  • Must be able to train and work in multiple production areas in the Formulation department including material movement, prep, and classified areas.

  • Must ensure training and gowning status is acceptable all time to ensure agility to work in aseptic production areas.

  • Must be able to complete training in all areas as required this includes all Formulation activity and aseptic filling and machine operation.

  • Prior or related cGMP or Pharmaceutical experience recommended

  • Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, manual dexterity, and ability to troubleshoot.

This position may be required to be moved or temporarily flexed to another department or building within the FFIP operation due to business needs. Some over-time/off-shift work hours may be required based on business needs. We will attempt to provide as much advance notice as possible, two weeks where applicable if any such change is needed.

What we offer

Sanofi Pasteur provides a total rewards employment offer including, but not limited to, competitive pay, industry-leading 401(k) match, immediate participation in comprehensive welfare benefits, tuition reimbursement (for Associates and Bachelors degree programs) and generous paid time off. Successful incumbents in the Vaccine Filling Technician have grown their career to other opportunities like Senior Production Technician, Lead Production Technician, or Principal Investigator, to name a few.

Become a member of the Swiftwater Industrials – the high-performing production team dedicated to the life-saving mission of Sanofi Pasteur!

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.

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