Job Title : Lead Production Technician

Location: Swiftwater, PA

About the Job

This position is 2nd shift, 3:00 PM - 11:30 PM

The Lead Production Technician is responsible for supporting the Manager with the day-to-day shop floor management, coordinating activities of production personnel and communication with support teams, and monitoring line performance to ensure production targets and quality standards are met whilst fostering a culture of working safely.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as a Production Operator within our Formulation and Filling Team, will have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

WHO WE ARE

Sanofi Pasteur is the vaccines division of Sanofi. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is located in northeast Pennsylvania and is home to the production of over 120 million doses of vaccine each year.

At Sanofi Pasteur’s Swiftwater site, we manufacture and market vaccines to help prevent diseases —some of which have 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. At the same time, we must adjust staffing during non-peak times.

Performs production in accordance with volume fluctuation, business needs, and effective procedures in the manufacturing area. This position is responsible for manufacturing activities in the assigned area. Also, possesses the ability to work independently to assist standard scheduled maintenance and perform minor equipment repairs.

During both Northern Hemisphere and Non-Peak periods technicians may be required to move to another department or location within the Swiftwater operations on a short-term, long-term, or permanent basis due to production needs. Technicians should expect to work in multiple buildings within the Biologics platform. Immunization against Influenza is required to operate within the manufacturing building. Some overtime work/off-shift work hours may be required based on business needs.

Summary of Purpose/Major Responsibilities

Key Accountabilities

• Coordinates daily operation in accordance with volume fluctuation, business need, and effective procedures. Continually monitors production activities with emphasis on safety, quality, efficiency and cost.

• Drives change over activates and targets

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

• Supports deviations and continuous improvement projects

• Participates/Leads in team meetings. Actively communicates improvement ideas, issues, concerns, etc to team members. Assist in leading the shift change meetings and is responsible for assisting in the distribution of the shift change report.

• Plan daily/weekly production activities based on Packaging planning schedule and works to schedule operators/technicians for production. Informs managers of any production problems or concerns and recommends solutions.

• 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.

• Is a trained designee to supervise shop floor activities including daily operations, maintaining adequate stock/supplies and maintenance needs.

• Ensure operational area is running as intended to meet all operational goals.

• Real time review of process documentation.

• Participates or leads in all aspects of production process (SAP, Labware, Trackwise/Phenix, Gibraltar, etc.).

• Works to resolve all production issues and understands next steps to guide others through the process to complete them.

• Ensure preparedness for oncoming shifts.

• Acts as a liaison with support groups as needed.

• Works with Senior Technicians and Managers to ensure continuous operation.

Dimensions/Scope

Their responsibilities are, but are not limited to:

Safety:

• Follows 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.

• Ensures proper training and safety practices are followed in the areas.

• Follows effective procedures to ensure the production of a safe and efficacious product.

• Utilizes +QDCI boards for Safety issues

Quality:

• FDA audit understanding and awareness. Ensures process in areas is following proper procedures at all times

• Identifies possible deviation occurrences and prevents or aids in investigations and root cause analysis.

• Ensures completion and review of quality documentation (PDR’s, logbooks, etc.) accurately in a timely manner for process area assigned.

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

• Writes edits and reviews process documentation for completeness.

• Identifies areas of deficiency and offers suggestions for improvements.

Delivery:

• Performs production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs

• Completes tasks and corresponding documentation as required by cGMP to ensure document completion and real time review.

• Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing.

• Accountable for the completion of Real Time SAP transactions in an accurate and timely manner to ensure accurate inventory.

• Post completion, reviewed PDR prior to PDR review delivery to ensure no documentation errors remain.

Cost:

• Executes procedure as documented to avoid deviations.

• Responsibly uses material in an efficient manner to reduce waste.

• Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.

• Works to resolve all production issues related to area of work.

Involvement:

• Works to become trained in all assigned training modules.

• Trains and orients new team members (at any level) as assigned. Mentors Associate and Production techs.

• Participates and leads team meetings. Understands respect, professionalism and confidentiality.

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

• Has a thorough working knowledge of cGMP’s and works to help others understand.

• Ensures all areas within the department are adequately covered at all time for current shift and upcoming shifts.

• In on time and attends and participates in Shift Change.

• Involved in at least one cross functional teams where necessary to complete projects in an effective and timely manner.

• 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.

All other duties as assigned.

About you

Requirements

Education/Experience

The Lead Production Technician is expected to have experience and knowledge including but not limited to the following:

• 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.

• Additionally must have 1 + year 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, 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.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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 FFIP 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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