Industrial Operations Manager

2 days ago

Dublin, Dublin City, Ireland beBeeProcessDirector Full time €104,000 - €130,878

Job Title: Process Director

About the Role

This is a unique opportunity to lead a team of professionals in the biopharmaceutical industry. As a Process Director, you will be responsible for setting the technical direction and overseeing the entire scope of work from initial concept to successful operation.

Key Responsibilities:
  • Set technical direction and oversee the scope of work from initial concept through to successful operation
  • Act as Technical Decision maker for area of scope
  • Review, accept and approve key technical documentation e.g.URSs,PIDs, FAT and SAT protocols
  • Work closely with site receiving team to prepare for handover and ensure smooth transition
  • Ensure User Requirement Specification (URSs) are produced and complete, technically accurate and appropriate for calibration and qualification execution
  • Provide strategic leadership to process improvement programmes sponsored by GERE or other senior stakeholders
  • Maintain business continuity and flag areas of concern
  • Support planning and implementation of commissioning and qualification activities
  • Lead process risk assessments to establish and deliver safe process operations and compliance when manufacturing products to quality standards
  • Provide leading input into process risk assessments (HAZOP,FMEA) to establish and deliver safe process operations and meet drug substance quality requirements
  • Be accountable for technical input into Design Review process and ensure project business objectives can be achieved
  • Provide technical support to facility, equipment, system in commissioning and qualification process
Desirable Skills and Qualifications
  • Experience with API (Small molecule) & Process design
  • Strong stakeholder management
  • Assess equipment needs and support generation of equipment URS and specifications for design or purchase
  • Experience with GMP URSs, which will be agreed with project stakeholders in basic design
  • Ensure requirements are understood and included in scope of works of designer
  • Consult in C&Q plan

The ideal candidate will have experience working in a similar role and possess strong technical skills. They will also have excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.

This is an exciting opportunity for a motivated and experienced professional to join our team and contribute to the success of our organization.

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