2nd Shift Vial Process Manager - Lead Aseptic Ops

BioSpace

Swiftwater (Monroe County)

On-site

USD 90,000 - 140,000

Full time

14 days+

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Benefits offered by this job

High-quality healthcare
Prevention and wellness programs
14 weeks parental leave

Job summary

Sanofi is seeking a Vial Process Manager in Swiftwater, PA to oversee shift operations, drive continuous improvement, and ensure strict adherence to cGMP and regulatory standards. The role requires strong leadership, project management, and capability to coordinate across manufacturing teams to meet quality and safety goals.

You will lead deviations investigations, CAPA development, and routine reviews, while fostering a culture of safety and continuous improvement in aseptic processing

Qualifications

  • Bachelor's degree in Life Sciences, Engineering, or related field with pharma manufacturing experience.
  • 3+ years in pharmaceutical manufacturing and/or development.
  • 7+ years in manufacturing/filling of biological products.

Responsibilities

  • Lead shift production management and schedule operations under GMP-compliant systems (eOOE, iObeya, Qualipso, SAP, Ocularis).
  • Perform 5W2H analyses, audits, real-time reviews, and CAPA investigations.
  • Identify and drive continuous improvement to enhance performance and reduce waste.
  • Coordinate cross-functional teams to align priorities with +QDCI standards.
  • Develop PCU and provide coaching and training to team members.
  • Support professional growth through training and certifications.

Skills

Detail-oriented
Time management
Analytical skills
Communication
Interpersonal skills
MS Office proficiency
SAP knowledge
Lean Manufacturing
Engineering background

Education

Bachelor's degree in Life Sciences/Engineering
7+ years experience in manufacturing/filling of biological products

Tools

eOOE
iObeya
Qualipso
SAP
Ocularis

Job description

Sanofi is seeking a Vial Process Manager in Swiftwater, PA to oversee shift operations, drive continuous improvement, and ensure strict adherence to cGMP and regulatory standards. The role requires strong leadership, project management, and capability to coordinate across manufacturing teams to meet quality and safety goals.

You will lead deviations investigations, CAPA development, and routine reviews, while fostering a culture of safety and continuous improvement in aseptic processing

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