Production TechnicianThis is an off-shift position within the B55 Recombinant Manufacturing FacilityQ1/Q2 will be 1st shift for project support before transitioning to assigned shift Who We AreAt Sanofi, we believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is in northeast Pennsylvania and is home to the production of over 120 million doses of vaccine each year. We manufacture and market vaccines to help prevent diseases —some of which have a seasonal demand. Given this seasonality, peak manufacturing periods require greater levels of labor, and it is important that we have the optimal number of employees to meet the demand.Who You AreYou are adaptable, and detail-oriented person who thrives in a fast paced, team environment.What you will DoThis position is to become part of the Production team to support the engineering, construction, qualification, validation, and licensure of the B55 Recombinant Manufacturing Facility. This position contributes as a member of a cross-functional team to support the startup of the cGMP manufacturing facility for Flublok /Panblok drug substance in Swiftwater PA and will later continue to support he cGMP commercial manufacturing of drug substances requiring a high degree of relationship building, communication, technical knowledge, and leadership.Summary of PurposeThis is an off-shift position. Some off-shift work will be required based on the project phase. As the project progresses into process executions, three shift coverage will be required and shift accommodation may be required. This position may be required to be moved or temporarily flexed to another department or building within the Biologics operations due to business needs. Additionally, candidates should expect to work in multiple buildings. Some overtime/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.Major Responsibilities:The Production Manufacturing Technician is a technical contributor to Flublok / Panblok manufacturing operations. The role is responsible for supporting the startup of the cGMP manufacturing facility for Flublok / Panblok drug substance in Swiftwater PA and will later continue to support the cGMP commercial manufacturing of drug substances. This role contributes to the overall safety, quality, compliance, productivity, and performance of the Sanofi / Protein Sciences Manufacturing group.Activities associated with the facility development and project execution will include, but will not be limited to the following:
Support execution of all engineering, definition, development, validation, and consistency batches.
Based on department assignment, you may be required to participate in the execution on the floor of Commissioning, Qualification, and Validation activities of production equipment and production processes. Responsibilities include equipment set-up, operations, troubleshooting, environmental monitoring, etc.
Follow all procedures put into effect to ensure your safety as well as the safety of others. Reports all safety issues, concerns, incidents, and near misses to the team leadership. Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.
Assist in development of electronic logbooks (eLogbooks) and electronic BRs (eBRs).
Participates or leads in all aspects of the production process (SAP, cycle counting, LIMS, material ordering, Labwatch, Medasys, DeltaV, Etc.).
Works to resolve all production issues and relays them to their leadership team.
Ensures all areas within the facility are adequately covered at all times.
Ensures that the team is thinking and working ahead whenever possible.
Completes tasks and corresponding documentation as required by cGMP.
Identifies deviations and aids investigations and root cause analysis.
Becomes trained in all assigned training modules.
Follows all procedures put into effect to ensure safety and the safety of others.
Reports all safety issues, concerns, incidents, and near misses to area management.
Must be able to lift 25lbs., bend/lift/move objects as part of the job.
Able to stand for up to 8 hours a day (with occasional breaks).
As this project progresses into later phases, the scope of this position will also focus on:
Follow Standard Operating Procedures (SOP) and batch records (BR) to produce commercial drug substance material.
Setup, cleaning, sterilization, and use of manufacturing equipment in the cGMP commercial manufacturing of Flublok / Panblok drug substance.
Works to complete quality documentation (BPR’s, logbooks, etc) accurately in a timely manner.
Ensures completion of sampling & corresponding documentation as required.
Ensures materials required for production are available as needed.
CFR (code of federal regulations) / PAI inspection readiness. FDA audit understanding and awareness.
Supports off-shift work as needed.
All other duties as assigned.
Basic Qualifications:
HS diploma or GED and 6 months+ in cGMP or pharmaceutical experience, military experience considered
Associates with 0+ years manufacturing experience
Preferred Qualifications:
Bachelor’s degree
Ability to use Human Machine Interfaces (HMI’s) to control industrial processes
Evidence of basic mechanical aptitude, computer skills, good comprehension skills, retention skills, manual dexterity, and ability to troubleshoot
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.#GD-SP#LI-SPAt 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.