Sanofi Group Senior Production Technician in Swiftwater, Pennsylvania

THIS IS A SECOND SHIFT POSITION. DURING THE PROJECT PHASE THE MAJORITY OF TIME WILL BE SPENT WORKING ON FIRST SHIFT. SOME OFF-SHIFT WORK WILL BE REQUIRED BASED ON THE PROJECT PHASE. PERMANENT SHIFT PLACEMENT WILL OCCUR SOMETIME IN 2020.

Participates in Commissioning, Qualification and Validation activities including document creation / editing, equipment set-up, operations and troubleshooting, environmental monitoring, process optimization, etc.

Performs production in accordance with volume fluctuation, business need, and effective procedures. Ensures all materials required for production are available prior to need. Ensures the completion of sampling and corresponding documentation as required. Ensures the completion of move tickets and picklists in an accurate and timely manner to ensure accurate inventory.

Participates or leads in all aspects of production process (SAP, cycle counting, Lims, Trackwise, ordering, Labwatch, Documentum, Medasys, DeltaV, etc.). Works to resolve all production issues. Understands next steps and works to guide others through the process to complete them. Understands science behind process steps and technology. Ensures all areas within the facility are adequately covered at all times. May serve as processing room leads and strive to become experts in their assigned areas. Completes tasks and corresponding documentation as required by cGMP

Continues development by completing at least one developmental class annually. Completes at least one developmental class outside of the core competencies annually. Works to become trained in all assigned training modules. Training coordinator / Trainer –Train and guide Personnel in proper work procedures, use of equipment, cGMP’s, safe work techniques and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.

Follows all procedures put into effect to ensure your safety as well as the safety of others. Participates in monthly safety meetings. Reports all safety issues, concerns, incidents and near misses to the team leadership. Actively participates in safety walkthroughs coordinated by the department’s safety team. Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions. Works with the safety team to ensure that the team is completing regular walkthroughs and is taking the necessary steps to address issues. Works with the safety team to ensure that the resources required to address safety issues are secured in a timely manner and that the effective resolutions are put into place and trained upon.

Works with the safety and leadership team to implement all safety initiatives by actively and effectively communicating the initiatives and by helping others to understand the initiatives.

Ensures training is completed on all safety implementations.

Follows effective procedures to ensure the production of a safe and efficacious product. Has a thorough working knowledge of the cGMP’s and works to help others understand. Identifies areas of deficiency and offers suggestions for improvements. Identifies deviations and aids in investigations and root cause analysis. Works to complete quality documentation (BPR’s, logbooks, etc.) accurately in a timely manner. Reviews quality documentation for completeness. Understands the function of the quality group and works with them to maintain a positive rapport.

Participates in cross functional teams where necessary to complete projects in an effective and timely manner.

All other duties as assigned.

Basic Qualifications:

High School diploma or equivalent and 3+ years cGMP manufacturing experience or 5+ years leading a team in a manufacturing environment

Associates with 2+ year manufacturing experience or Associates in a science related field with 1+ year manufacturing experience

Bachelors with 1+ years manufacturing experience

Preferred Qualifications

Prior or related cGMP, Pharmaceutical, or other industrial quality management system (ISO 9000, etc.) experience

Proficiency in any of the following areas preferred: Batch record review, environmental monitoring, documentation coordinator, logbook review, technical writing, SAP, PI Historian

Basic mechanical skill (use of hand tools, equipment troubleshooting experience, etc.)

Sanofi Pasteur SA 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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life