Lead Production Technician Packaging & Label Control - Vaccines

SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES

The Lead Production Technician is responsible for performing production in accordance with volume fluctuation, business needs, and effective procedures within the Packaging & Label Control Department.

Additionally, the Lead Production Technician is responsible for all the activities in addition to those of a Sr. Production Technician and Label Control.

This position interacts with filling, inspection, staging, warehouse, supply chain/procurement, quality assurance, quality validation, HSE, continuous improvement, regulatory, and the vaccines leadership teams

Key Accountability

50% of the time

• Performs production in accordance with volume fluctuation, business needs, and effective procedures.

• Follows all SMS principles including the shift change process and +QDCI.

• Ensures all documentation required for production are available prior to need.

• Ensures the completion of sampling and corresponding documentation as required.

• Ensures the completion of SAP transactions in an accurate and timely manner to ensure accurate inventory.

• Participates or leads in all aspects of the production process (Label Control, SAP, cycle counting, Lims, ordering, Labwatch, GEOD + SFD, etc.).

• Works to resolve all production issues.

• Understands next steps and works to guide others through the process to complete them.

• 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.

10% of the time

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

• Completes at least one developmental class outside of the core competencies annually.

• Training Coordinator / Trainer –Train and guide Personnel in proper work procedures, use of equipment, cGMPs, safe work techniques, and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.

5% of the time

• Follows all procedures put into effect to ensure your safety as well as the safety of others.

• Participates daily + QDCI reviews are completed.

• Reports all safety issues, concerns, incidents, and near misses to the team leader.

• Holds themselves and the team accountable to always follow HSE.

• Works with both the safety and leadership team to ensure that the resources required to address safety issues are secured in a timely manner.

• Ensures training is completed on all safety implementations.

10% of the time

• Has a thorough working knowledge of the cGMPs and works to help others understand.

• Identifies areas of deficiency and offers suggestions for improvements.

• Identifies deviations and aids investigations and root cause analysis.

• Works to complete quality documentation (deviation investigations, PDR’s, logbooks, etc) accurately in a timely manner.

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

• Understand the function of the quality group and work with them to maintain a positive rapport.

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

10% of the time

• Participates/Leads in shift change meetings following the SMS principles.

• Works to help maintain positive working relationships between all team members. Leads by example and works to help others understand the value of diversity.

• Assist in ensuring that shift change reports and meetings are completed in an accurate including the scheduling of the lines. Mentors team members as it relates to the overall manufacturing process, situational awareness, and previous lessons learned.

10% of the time

• Packaging Lead Operator are also Subject Matter Experts that ensures quality and right the first-time efforts.

• May be responsible for the scheduling of staff assignments, addresses all inquires of internal customers (R&D, IO, QA, QA, Global, RA, etc.) components, procedures, and equipment.

• Plan daily/weekly production activities based on Packaging planning schedule and works to schedule operators/technicians for production runs qualification, testing, projects, etc.

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

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

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

• Understands the 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.

• Writes, reviews, and revises PDR’s, SOP’s and SWI’s as needed. Continually monitors production activities

5% of the time - All other duties assigned

CONTEXT OF THE JOB/MAJOR CHALLENGES

The GMP production environment requires attention to the details and accuracy within good documentation practices. The multi-shift GMP production environment that exists generates the need to work overtime as required often with short notice and the working of various shifts depending on business needs and production cycles. The focus to create and maintain a safety culture that is proactive and striving for zero injuries is of the utmost importance and an expectation for all employees.

EDUCATION/EXPERIENCE

• HS equivalent 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.

• Additionally, must have 1 + years leading teams in a Production environment. 1 + years training others in cGMP tasks.

• Must be considered an SME in at least one processing area.

• Must have training coordinator access in Isotrain and be able to enter training into the system.

• Must be qualified to complete PDR final reviews.

• 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).

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

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

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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-SP

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.