Process Development Specialist

3 days ago

Limerick, Limerick, Ireland beBeeChemistry Full time
Job Title

A highly skilled professional is sought after to lead or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices.

  • Maintain high expertise in regulatory topics such as FDA, US Pharmacopeia, European Pharmacopeia, and ICH guidelines.
  • Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions.
  • Review data and reports for accuracy and consistency with regulator's expectations.
  • Collaborate with stakeholders to identify contract manufacturers, API vendor selection, qualification, and audits.
  • Lead or participate in engineering projects as a subject matter expert within the field of CMC and test method development.
  • Provide input on new product introduction and assessing proposed manufacturing changes.
  • Support Investigation/Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations.
  • Collaborate with Post Market/Manufacturing Engineering Teams to ensure effective completion of activities associated with Post Market Engineering projects/objectives.
Requirements

Requirements for this position include:

  • Bachelor's degree or higher in engineering/science or related field.
  • Minimum 3 years relevant experience with CMC.
  • Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP/GLP regulated industry standards.
  • Familiarity with FDA, US Pharmacopeia, European Pharmacopeia, and ICH CMC regulatory topics.
  • Proven analytical and problem-solving skills.
  • Strong interpersonal skills and ability to communicate across functions.
  • Familiarity with statistical methods, analysis, and interpretation.
  • Ability to work on multiple projects, organize, and prioritize within time constraints.
  • Familiarity with Microsoft Office software.

This is an excellent opportunity to join our team and contribute to the success of our company. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.

  • Process Optimisation Specialist

    20 hours ago

    Limerick, Limerick, Ireland beBeeProcess Full time €50,000 - €80,000

    Job Title: Process Optimisation SpecialistThis is an exciting opportunity to join our team as a Process Optimisation Specialist.We are looking for a highly motivated and experienced professional to provide engineering support to processes, projects, or functions.As a Process Optimisation Specialist, you will be responsible for applying fundamental...

  • Business Process Specialist

    44 minutes ago

    Limerick, Limerick, Ireland Quanta part of QCS Staffing Full time

    Business Process Specialist – Limerick, Ireland - Contract Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client's side for a global Pharmaceutical organisation on a...

  • Principal Sterilization Process Specialist

    22 hours ago

    Limerick, Limerick, Ireland beBeeSterilization Full time €50,000 - €60,000

    Job Title: Principal Sterilization Process SpecialistAbout the Role:We are seeking a highly skilled and experienced sterilization process specialist to join our team. As a principal sterilization process specialist, you will be responsible for developing and validating sterilization methods for medical devices.You will work closely with cross-functional...

  • Process Development Specialist

    18 hours ago

    Limerick, Limerick, Ireland beBeeRegulatory Full time €80,000 - €100,000

    CMC Regulatory ExpertiseThis strategic role involves maintaining high-level expertise in FDA, US Pharmacopeia, and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics.Key Responsibilities:Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions.Ensure data and reports are...

  • Senior Chemist

    1 day ago

    Limerick, Limerick, Ireland beBeeProcess Full time €90,000 - €120,000

    We are seeking a skilled Process Development Specialist to join our team in Limerick. This role focuses on process and problem-solving, with opportunities for flexible working arrangements.Develop and maintain expertise in regulatory guidelines related to chemistry, manufacturing, and controls (CMC) topics.Promote the development of CMC strategies to support...

  • Senior Process Development Specialist

    2 weeks ago

    Limerick, Limerick, Ireland beBeeChemistry Full time €75,000 - €90,000

    Process Chemist RoleThe primary objective of this position is to oversee and/or participate in projects focused on developing strategies related to chemistry, manufacturing, and controls (CMC) of combination drug devices. The successful candidate will provide oversight in method development and validation, compendial method verification and transfer,...

  • Support Process Lead

    1 hour ago

    Limerick, Limerick, Ireland beBeeProcessImprovement Full time €65,600 - €80,800

    Customer Support SpecialistA key role in our organization, the customer support specialist is responsible for analyzing and developing strategies to enhance operational efficiency, reduce costs, and improve business processes.The role involves drive continual improvement to enhance the customer experience.Investigate, analyze, and document current business...

  • Process Development Engineer

    22 hours ago

    Limerick, Limerick, Ireland beBeeManufacturing Full time €55,000 - €70,000

    Job Title: Process Development EngineerThe primary focus of this role is to develop and execute test method validations for equipment in accordance with current quality management system and regulatory standards.Develop and implement medical device manufacturing processes as assigned, ensuring adherence to established guidelines and protocols.Identify...

  • Business Development Specialist

    3 weeks ago

    Limerick, Limerick, Ireland Alliance Medical Ireland Full time

    Join to apply for the Business Development Specialist role at Alliance Medical Ireland4 days ago Be among the first 25 applicantsJoin to apply for the Business Development Specialist role at Alliance Medical IrelandGet AI-powered advice on this job and more exclusive features.Alliance Medical are recruiting for a Business Development Specialist for the Kerry...

  • Internal Audit Process Enhancement Specialist

    1 day ago

    Limerick, Limerick, Ireland beBeeAudit Full time €70,000 - €92,000

    Job DescriptionAudit Specialist with a focus on strengthening business processes and controls through comprehensive internal audits.This is a high-impact position that requires strong understanding of internal controls, risk management, and audit methodology. You will work closely with senior audit professionals, perform detailed audit testing, and...