Process Validation Engineer

7 days ago


Cork, Cork, Ireland QCS Staffing Full time

Process Validation Engineer, Drug Substance - Cork, Ireland - 12 Months Contract

Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases?

This is a fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading Biopharmaceutical company who focus on a range of products which are life-changing for individuals.

Responsibilities Include:

  • Perform process validation activities related to Client's drug substance and drug products, through defined clinical and commercial stages.
  • Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising supervised judgement within broadly defined procedures and practices to establish acceptance criteria, and to identify and implement solutions to meet Client's and Health Authority requirements.
  • Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
  • Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
  • Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures.
  • May participate on sub-teams.
  • Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by the Client, validation techniques/approaches and systems utilised by the Client.

Requirements:

  • Experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
  • Experience in a position utilising formal project management a plus.
  • Organisational and management skills to participate in multi-discipline project groups.
  • Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate.
  • Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations.
  • Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations.

If this role is of interest, please apply now

Seniority level

Entry level

Employment type

Contract

Job function

Quality Assurance

Industries

Staffing and Recruiting

#J-18808-Ljbffr
  • Validation Engineer

    3 weeks ago


    Cork, Cork, Ireland Ellab - Validation & Monitoring Solutions Full time

    Join Ellab on our exciting growth journey as a Validation Engineer for opportunities in the Cork Area.Are you a passionate and experienced Validation Engineer? If so, we have an exciting opportunity for you to join our team at Ellab Ireland, a leading provider of innovative compliance solutions for the pharma industry.Responsibilities:Set up of Ellab...


  • Cork, Cork, Ireland TN Ireland Full time

    We are currently recruiting for Process Validation Engineers on a contract basis for a leading Pharmaceutical company based in Cork.Process Validation Engineer:I am currently seeking an experienced Process Validation Engineer to join a Pharmaceutical company based in Cork. You will be responsible for the execution, review and approval of validation...


  • Cork, Cork, Ireland Quanta Consultancy Services Ltd Full time

    Process Validation Engineer, Drug Substance - Cork, Ireland - 12 Months ContractAre you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases?This is a fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading...


  • Cork, Cork, Ireland Quanta Consultancy Services Ltd Full time

    Process Validation Engineer, Drug Substance - Cork, Ireland - 12 Months ContractAre you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases?This is a fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading...


  • Cork, Cork, Ireland Life Science Recruitment Full time

    We're currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties1. Ensure validation activities completed comply with US and EU regulations, GBSC procedures and EHS...


  • Cork, Cork, Ireland Expo Process Analytics Full time

    The role of Process Development Engineer at Expo Process Analytics supports the development of engineered products using advanced powder flow characterizations.We are seeking a skilled Mechanical Engineer to join our team and contribute to the creation of innovative test methods ensuring accurate analysis and optimization of powder handling processes for...


  • Cork, Cork, Ireland Expo Process Analytics Full time

    Engineering Process AnalystIn this role, you will have the opportunity to work closely with our engineering team to develop departmental processes, procedures, and best practices.You will be responsible for preparing detailed product specifications, conducting lab-based investigations, and developing solutions to improve powder flow characteristics.The ideal...


  • Cork, Cork, Ireland Life Science Recruitment Full time

    We're recruiting for a talented Process Validation Expert to join our Medical Device organization in Limerick.About the RoleDevelop and implement process validation strategies to ensure compliance with regulatory requirements.Collaborate with cross-functional teams to execute process validation activities, including OQ & PQ, SOPs, and GMPs.Apply six sigma...


  • Cork, Cork, Ireland TN Ireland Full time

    Validation Experts Sought - Biopharmaceutical IndustryTN Ireland invites applications for experienced Cleaning Validation Engineers to join their client, a leading biopharmaceutical company, in Cork. As a key member of the team, you will play a critical role in ensuring the highest standards of cleaning validation are met, adhering to regulatory...


  • Cork, Cork, Ireland Quanta Consultancy Services Ltd Full time

    Company Overview:Celebrating a century of commitment to developing advanced treatments for rare diseases, Quanta Consultancy Services Ltd is a world-leading biopharmaceutical company. Our mission is to revolutionize the lives of individuals suffering from debilitating conditions.Job Description:We are seeking an exceptional Process Validation Engineer to...


  • Cork, Cork, Ireland Fastnet Full time

    The role will have a significant part in the approval of documentation and support for release of manufacturing systems and processes for cGMP use. This position is required to successfully complete projects in a timely manner supporting company goals and objectives. Decisions made by this position can significantly affect project timelines and the ability...


  • Cork, Cork, Ireland LSC, Life Science Consultants Full time

    Global MSAT Process Validation Engineer (BBBH28187) Cork, Republic of IrelandLSC have a great contract opportunity for Global MSAT Process Validation Engineer to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow,...

  • Validation Engineer

    3 hours ago


    Cork, Cork, Ireland TN Ireland Full time

    Job DescriptionA Validation Engineer is required by CareerWise Recruitment for our Co Cork based med device client.Role of this positionOwn and support validation activities in a Medical Device regulated environment.Responsible for all Process Validation Executions.Responsible for all Software Validation Executions.Resolution of Problems encountered during...

  • Validation Engineer

    22 hours ago


    Cork, Cork, Ireland Life Science Recruitment Full time

    Life Science Recruitment is currently seeking a highly skilled Process Validation Engineer to join an award-winning Medical Device organization based in Ireland. This exciting opportunity will provide the successful candidate with the chance to work for a leading multinational company that is renowned for its excellence in the industry.About the RoleThe...

  • Validation Engineer

    6 days ago


    Cork, Cork, Ireland i-Pharm Consulting Full time

    Title: Senior Validation EngineerContract Duration: 12 MonthsLocation: County Waterford, IrelandAre you looking for a way to make a real impact? As a Senior Validation Engineer, you will play a key role in ensuring compliance within a cGMP-regulated environment, with a focus on Cleaning Validation, including Recovery and Cleanability studies.This is a great...


  • Cork, Cork, Ireland Life Science Recruitment Full time

    We are seeking a Validation Engineer Lead to join our Medical Device organization in Limerick.About the RoleLead cross-functional teams to develop and implement process validation strategies.Ensure compliance with regulatory requirements through process validation activities, including OQ & PQ, SOPs, and GMPs.Utilize six sigma statistical analysis and...


  • Cork, Cork, Ireland TN Ireland Full time

    Cleaning Validation Engineer - Life Science - Cork - 12-Months+ ContractWe have a great opportunity for Cleaning Validation Engineers to join our client, a research-based biopharmaceutical company, on their journey of discovering, developing, and commercialising innovative medicines and researching and developing antiviral drugs used in the treatment of...


  • Cork, Cork, Ireland PE Global (UK) Full time

    Role Summary:We are seeking a highly skilled Technical SME to join our team as a Senior CQV Engineer. In this role, you will be responsible for leading a team of validation engineers, developing and implementing validation strategies, and ensuring compliance with regulatory requirements.Responsibilities:Leading a team of validation engineers to achieve...


  • Cork, Cork, Ireland QCS Staffing Full time

    Serve as a Process Validation Specialist at QCS Staffing and play a crucial role in ensuring the quality and integrity of our clients' products. This is an excellent opportunity to join a world-leading biopharmaceutical company focused on developing life-changing treatments for individuals suffering from rare diseases.Your key responsibilities will include...


  • Cork, Cork, Ireland Life Science Recruitment Full time

    We're currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.DutiesCompetent in process validation requirements on new manufacturing processes, equipment introductions &...