Lead Production Technician - Vaccine

Lead Production Technician - Vaccine

THIS IS A SECOND SHIFT POSITION

JOB RESPONSIBILITIES:

• 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. 

• Seeks out next steps and advises team as to what can be completed. 

• Ensures that the team is planning and working ahead whenever possible. 

• 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.

• Leads the safety team to ensure that the team is completing regular walkthroughs and is taking the necessary steps to address issues. 

• Works with both the safety and leadership 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 (deviation investigations, BPR’s, logbooks, etc) accurately in a timely manner. 

• Reviews quality documentation for completeness and releases commodities as required. 

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

• Works with the quality group/technical services group, as required, to ensure timely completion of deviation investigations, change controls, documentation, and CAPAs. 

• Ensures implementation of effective solutions to both deviations and deficiencies identified by our group or the quality unit.

• Participates/Leads in team meetings. 

• Actively communicates improvement ideas, issues, concerns, etc to team members. 

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

• Works to help maintain positive working relationships between all team members. 

• Leads by example and works to help others understands the value in diversity. 

• Ensures that there are open lines of communication between all team members.  

•  Assist in leading the shift change meetings and is responsible for assisting in the distribution of the shift change report. 

• Assist in ensuring that shift change reports and meetings are completed in an accurate, effective and timely manner.

• Mentors team members as it relates to the overall manufacturing process, situational awareness and previous lessons learned.

• Lead Operator or Room Lead or Subject Matter Expert that ensures quality and right the first time efforts. 

• May provide leadership across one or more processing areas.

• May be responsible for scheduling of staff assignments, Addresses all inquires of internal customers (R&D, IO, QA, QA, Global, RA, etc..) dealing with media, reagents, supplies, intermediates and equipment. 

• Identifies issues and takes action to ensure that continuous incremental improvements are made in decreasing operator errors. 

• Informs managers of any production problems or concerns and recommends solutions. 

• Ensures processes / operations are documented in a timely and accurate manner. 

• Understands entire process, and demonstrates follow through in moving a process forward. Is aware of other departments and business areas, what they do, and how they fit into the overall objective of marketing and delivering products and services. 

• Systematically breaks down problems using standard approaches that have proven successful in the past.  

• Fully investigates and understands root causes of deviations in a step-by-step way. 

• Writes, reviews, and revises BPR’s, SOP’s and SWI’s as needed. 

• Initiates change controls and CAPA’s and follows them to completion.

• Continually monitors production activities with emphasis on safety, quality, efficiency and cost. 

• Cooperates willingly with colleagues, establishes rapport in a friendly and courteous manner. 

• Ensures site safety and HR policies are complied with and communicates issues immediately.

• Works with management to identify development opportunities for technician staff. 

• Coordinates the repair, PM’S and calibration of all equipment. All other duties as assigned

BASIC QUALIFICATIONS:

• Experience in a cGMP area. Prior or related experience recommended. 

• Must have knowledge and access to systems (SAP, Trackwise, Master Labware, HSE Trackwise, key user access to SAP).

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

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

• Additionally must have 1 + year leading teams in a Production environment.  

• 1 + years training others in cGMP tasks. 

• For Filling- Aseptic Processing experience preferred.

• HS equiv and 5+ in cGMP or Pharmaceutical experience

• Associates with 3+ in cGMP or Pharmaceutical experience

• Bachelor's with 2+ in cGMP or Pharmaceutical experience

• Must meet all Sr. Production Technician requirements.  

PREFERRED QUALIFICATIONS:

• Filling Aseptic Processing experience

THE FINE PRINT :

• For influenza production roles (excluding FFIP roles): candidate must be able to be receive influenza vaccine which is required for building access

• For aseptic area production roles (excluding Flu production tech roles): candidate must be able to obtain and maintain current aseptic gowning qualification

• This position may be required to be moved or temporarily flexed to another department or building within the Biologics operation due to business needs. Additionally, candidates should expect to work in multiple buildings. 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.

• Must be able to lift up to 25 lbs., and bend/lift/move objects as part of the job.

• Able to stand for up to 8 hours a day (with occasional breaks)

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.