BSA Lead Production Technician

Sanofi • Swiftwater, PA

4d • $27 - $36 • Onsite

About The Position

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

• Experience in a cGMP area.
• Prior or related experience recommended.
• Must have knowledge and access to systems (SAP, key user access to SAP).
• Must have knowledge and access to systems in applicable buildings and processes which have these systems (SFD, PI).
• Must be qualified to complete BPR section reviews
• Requires good mechanical skills, computer skills and is detail oriented.
• Must have basic mechanical aptitude, good comprehension skills, retention skills, troubleshooting and manual dexterity.
• 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

Nice To Haves

• Meet all Sr. Production Technician requirements.
• Additionally have 1 + year leading teams in a Production environment and 1 + years training others in cGMP tasks

Responsibilities

• Performs production in accordance with business needs, 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.
• Must have access to systems (SAP, Trackwise, and Labware).
• Must have access to systems in applicable buildings and processes which have these systems (SFD, PI, Metasys, Labwatch)
• 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.
• Utilizes +QDCI boards for Safety issues
• 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 within the BSA areas, 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, 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 BSA 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.
• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level