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Senior Sterile Manufacturing Engineer

2 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

About PSC Biotech Corporation

PSC Biotech Corporation is a leading biotechnology consultancy firm that has been serving clients in over 23 countries worldwide since its founding in 1996. Our global operations span across Ireland, India, Singapore, Australia, and the US.

  • We provide innovative cloud-based software solutions for quality management and regulatory inspections to pharmaceutical contract manufacturing professionals.
  • Our metrology services cater to the diverse needs of our clients across various industries.

'Take your Career to New Heights'

PSC Biotech disrupts the conventional consultancy model by offering permanent employment contracts with opportunities to work on top pharmaceutical client sites in a diverse cultural environment.

Employee Value Proposition

At PSC Biotech, we believe that our employees are the driving force behind our success. We empower them through continuous learning and development opportunities, providing mentorship and guidance to facilitate career growth.

Job Overview:

  • This Senior Sterile Manufacturing Engineer will play a crucial role in the development of client site drug product facilities.
  • The successful candidate will lead activities to deliver technical transfer requirements needed to support new product introductions.
  • This includes executing validation programs & strategies, providing technical support, and managing process improvement projects, as well as network support & collaboration.
Key Responsibilities:
  • The ideal candidate will collaborate across functions, supporting, coaching, and facilitating project sub-teams.
  • Together, this dynamic group will meet the required project schedule milestones, in accordance with applicable standards for quality and EHS compliance.
Requirements:
  • Safety:
    • Collaborate with multiple partners to drive a safe and compliant culture.
    • Represent Technical Engineering at Global Technical Forums as required.
  • Compliance:
    • Execute current Good Manufacturing Practices (cGMP) in day-to-day activities and all job functions.
    • Document completion, risk assessments, closing out corrective action, participate in audits and inspections, and highlight any issues around compliance.
  • Process Engineering & Validation:
    • Lead and execute process engineering and validation activities to support technical transfers.
  • Projects:
    • Lead and manage multiple Technical Engineering projects needed to support business growth.
    • Manage and deliver on technical/Validation/Quality Notification/Change control/Project support within the technical engineering team.
    • Sponsor and foster lean six sigma and standard work within the technical engineering team.
  • Technical Expertise:
    • Act as a subject matter expert on equipment design, C&Q execution and planning, process design, and validation.
    • Assist in collaborating with global engineering services, facilities, and specialist vendors on process requirements to deliver projects.
Qualifications, Skills, and Education Required:
  • Considerable experience in a comparable role, typically operating as a senior professional adding value to the business.
  • Proven track record in delivering results in a world-class supply organization.
  • A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment.
  • Innovative thinker with excellent decision-making and problem-solving skills.
  • Experience working in a cross-functional environment.
  • Knowledge of Six Sigma and Lean methodologies.