Lead Production Technician - Vaccines
Company: Sanofi Group
Posted on: January 27, 2023
Lead Production Technician VaccinesJOB 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
- Seeks out next steps and advises team as to what can be
- Ensures that the team is planning and working ahead whenever
- Completes tasks and corresponding documentation as required by
cGMP Continues development by completing at least one developmental
- Completes at least one developmental class outside of the core
- Works to become trained in all assigned training modules.
- 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
- 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
departments 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
- 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
- Ensures training is completed on all safety
- Follows effective procedures to ensure the production of a safe
and efficacious product.
- Has a thorough working knowledge of the cGMPs and works to help
- Identifies areas of deficiency and offers suggestions for
- Identifies deviations and aids in investigations and root cause
- Works to complete quality documentation (deviation
investigations, BPRs, logbooks, etc) accurately in a timely
- 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
- 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
- Ensures that there are open lines of communication between all
- 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
- 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
- Informs managers of any production problems or concerns and
- Ensures processes / operations are documented in a timely and
- 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 BPRs, SOPs and SWIs as needed.
Initiates change controls and CAPAs and follows them to
- 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
- Coordinates the repair, PMS and calibration of all
- All other duties as assignedJOB REQUIREMENTS:
- Candidate must meet all Sr. Production Technician
- Additionally must have 1 + year leading teams in a Production
- 1 + years training others in cGMP tasks.
- 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,
- Requires good mechanical skills, computer skills and is detail
- Must have basic mechanical aptitude, good comprehension skills,
retention skills, troubleshooting and manual dexterity.
- HS equivalent and 5+ in cGMP or Pharmaceutical experience
- Associates Degree with 3+ in cGMP or Pharmaceutical
- Bachelor's Degree with 2+ in cGMP or Pharmaceutical
- Filling Aseptic Processing experienceAs 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.According to the CDC, an individual is
considered to be fully vaccinated fourteen (14) days after
receiving (a) the second dose of the Moderna or Pfizer vaccine, or
(b) the single dose of the J&J vaccine. Fully vaccinated, for
new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO
START DATESanofi 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.
Keywords: Sanofi Group, Scranton , Lead Production Technician - Vaccines, Professions , Swiftwater, Pennsylvania
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