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Process Lead

Date Posted: May 3, 2024

Job Description

Are you an experienced professional with a background in managing external vendors for pharmaceutical projects? Do you possess technical expertise in process engineering within biologics manufacturing facilities? Anter Consulting is seeking a talented individual to join our team as a Process Lead in Ireland.

Key Responsibilities

  • Serve as the primary point of contact for all process packages, ensuring alignment with operational requirements.
  • Manage project budgets, resources, and timelines to ensure successful and on-time project delivery.
  • Lead Quality Event (Deviation) process and Change Control for Process Engineering.
  • Provide support for CAPEX projects, including timely implementation and closure.
  • Collaborate with cross-functional teams and global engineering functions to drive process improvements and standardization.
  • Ensure equipment capability, fit-for-purpose, and adherence to business needs.
  • Provide training to end-users on technical aspects of installed plant assets and support the evaluation and implementation of new technology for process execution and analysis.

Required Qualifications and Skills

  • Proven experience managing external vendors for the planning, design, and construction of pharmaceutical projects.
  • Previous involvement in Pharmaceutical NPI/Tech Transfer/GreenField projects.
  • Proficiency in Functional Specification Management and familiarity with change control processes and systems.
  • Knowledge of process safety assessments, hazard identification tools, and process FMEAs.
  • Deep understanding of pharmaceutical industry standards and regulations, particularly FDA regulations.
  • Specific experience in biologics manufacturing processes and systems, with familiarity with GMP and other quality standards.
  • Strong project management and organizational skills, with the ability to manage multiple tasks simultaneously.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.

If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E

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