Senior Production Technician

Sanofi; Pennsylvania; On-site; USD 40,000 - 80,000; Full time

Job summary

Join a forward-thinking company as a Senior Production Technician, where your skills will contribute to delivering healthcare solutions to millions. In this pivotal role, you will ensure the operational area runs smoothly, adhering to safety and quality standards while participating in crucial documentation and investigations. With a focus on continuous improvement, you will work alongside a dedicated team, fostering a dynamic and inclusive workplace. This position offers a chance to grow your career in a supportive environment that values your contributions and encourages professional development. Embrace the opportunity to make a real difference in the lives of patients and their families.

Benefits

High-quality healthcare

Wellness programs

Gender-neutral parental leave

Career growth opportunities

Qualifications

• Requires good mechanical and computer skills, detail-oriented with troubleshooting abilities.
• Prior cGMP or Pharmaceutical experience is recommended.

Responsibilities

• Ensure operational area meets all goals and safety procedures.
• Participate in quality documentation and incident investigations.

Skills

Mechanical Skills

Computer Skills

Detail-oriented

Troubleshooting

Manual Dexterity

cGMP Knowledge

Education

High School Diploma or Equivalent

Associate's Degree

Bachelor's Degree

Tools

SAP

Trackwise

Labware

SCADA

Job description

Senior Production Technician

Job Title: Senior Production Technician

Location: Swiftwater, PA

About the Job

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.

The Senior Production Technician will:

• Ensure operational area is running as intended to meet all operational goals.
• Ensure the completion of Environmental Monitoring sampling and corresponding documentation, data entry, and delivery as required during all aseptic processing. Real-time review of this documentation.

Main Responsibilities:

Safety:

• 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.
• 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.
• Participates in completing at least one incident investigation, one CAPA action item, or one change control action item, along with projects.
• Ensures completion and review of quality documentation (BFR’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.
• Maintains acceptable execution with no emerging negative trends in procedural deviations.

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.
• Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all aseptic materials.
• Ensures proper aseptic setup and installation of aseptic fill parts and Filler setup. This is done in a Grade A environment. Must ensure maintenance of gowning and physical dexterity to complete proper setup of machines so as not to impact the safety, quality, and integrity of the product.
• Ensures all Final Container materials required for production are available prior to need. These materials must be ready for aseptic filling operations to ensure the safety, quality, purity, and integrity of the product is maintained.
• Ensures the completion of Real Time SAP transactions in an accurate and timely manner to ensure accurate inventory.

Cost:

• Executes procedure as documented to avoid deviations.
• Responsibly uses material in an efficient manner to reduce waste.
• Utilizes Filling Standards to capture and Record HRxHR and Change Over Activities.
• Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.
• Works to resolve common 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.
• Participates and leads team meetings. Understands respect, professionalism, and confidentiality.
• Ensures all areas within the department are adequately covered at all times for current shift and upcoming shifts.
• Involved in cross-functional teams where necessary to complete projects in an effective and timely manner.
• 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.
• Must be able to complete and maintain qualification of utility sampling.
• Participates or leads in all aspects of production process (SAP, Labware if required, Trackwise, RT Reports, eDoc, HMI, SCADA access, Virtual Standards, etc.).
• Works to resolve all production issues. Understands next steps and works to guide others through the process to complete them.
• Ensures operational area is adequately staffed at all times.
• May serve as Preparation or Aseptic room leads and strive to become experts in their assigned areas.
• Works with lead technicians and managers to ensure continuous operation.
• Maintains aseptic work environment.

About You

REQUIREMENTS:

• Requires good mechanical skills, computer skills, and is detail-oriented.
• Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting, and manual dexterity.
• Prior or related cGMP or Pharmaceutical experience recommended.
• HS diploma or equivalent and 3+ years in cGMP or Pharmaceutical experience.
• Associates with 2 + yrs in cGMP or Pharmaceutical experience.
• Bachelor’s with 1 + yrs in cGMP or Pharmaceutical experience.
• Proficiency in at least but not limited to three areas of operations or product line. Must be proficient in at least one of the following areas: BFR review, Environmental monitoring, Utility Sampling, Documentation Coordinator, logbook review, technical writing (SWI revisions).
• Must have knowledge and access to systems (SAP, Trackwise, Master, EMS, PMS, SCADA, RTReports, Labware).

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.

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.

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

About Us

Sanofi

Why Sanofi

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.