Validation Engineer (Pharma)

Looking to join a well-established pharmaceutical company? One of Ireland’s leading healthcare companies is looking for a Validation Engineer to join their team on an 11-month contract in Cork.  

Job responsibilities:

• Ensure highest Quality, Compliance and Safety standards primarily Technical/ Validation activities
• Project validation support including conducting equipment performance qualifications (cleaning and sterilization validation periodic reviews, re-qualifications, temperature mapping)
• Authoring project validation master plans, SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data
• Experience with audits and preparation for audits
• Technical review, ownership of and approval of Global Change Management records as required

Job requirements:

• Minimum 2 years validation experience
• Hons Degree or Masters in a Science or Engineering discipline
• Preference for Lean Six Sigma qualifications

If you would like to discuss this job, please reach out to Louise Whitty on 021 2359140 /

lwhitty@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Summary:
Our client is a global biopharma company based in Carlow and is looking for a Process Engineer who will provide technical support for commercial manufacturing and new product introduction. The right candidate will perform product risk management and quality risk management and will Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support and qualification/validation documentation and studies in line with the standard approval process.

Responsibilities:

• Serve as technical support for commercial manufacturing and new product introduction.
• Product risk management and quality risk management.
• Management of change.
• Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input into quality notification by authoring/reviewing/approving investigations.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation.
• Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
• Statistical data analysis to support development and commercialisation batches.
• Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation reports.
• Execution/development of change controls.
• Contribution to Kaizen events as appropriate.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
• Implement subsequent corrective action through the change management system.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• Key process engineer in the commercial products engineering team to address and lead any management of changes, risks, impact assessments etc. associated with the commercial products.
• Role will report to Technical Engineering commercial support coach.

Qualifications & Experience:

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• 3-5 years’ Engineering/Technical experience; ideally in manufacturing, preferably GMP Setting.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Proficiency in Microsoft Office and job related computer applications required.
• Data analysis experience required.
• Lean Six Sigma Methodology experience desired.

An exciting career opportunity awaits with a global medical devices company based in Cork for a Supplier Quality Engineer on a 12 months' contract.

Job Responsibilities of Supplier Quality Engineer:

• Providing engineering support for activities related to supplier selection and evaluation.
• Contributing to the development, maintenance and improvements of supplier quality policies and procedures.
• Reviewing and approving all material and component specification drawings.
• As a Supplier Quality Engineer you will be assessing supplier capabilities through direct visits, technical discussions and quality system audits.
• Contributing to and participating in Material Review Boards & supplier performance reviews.
• Evaluating and establishing Supplied Data Agreements with suppliers.
• Working with product line engineering to assess and address material quality issues.
• Demonstrating a thorough understanding of related quality standards, including ISO and GMP.
• As a Supplier Quality Engineer you will be assisting in establishing and implementing Supplier QA Department improvement goals.
• Evaluating in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Travel will be expected in this role.

Job Requirements:

• Bachelor’s Degree in relevant discipline (min Level 8)
• 2+ years experience in an Engineering / Quality role
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical and problem solving skills.
• Knowledge of Quality System Requirements
• Proven track record of working in a fast paced environment with strong technical capabilities
• Capable of handling multiple development aspects of assigned projects

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Do you want to be part of a Global innovative Health Care Company?

If you are a Senior Quality Engineer, then this job opportunity is for you!

Job Responsibilities

• Supervision of Quality Technicians and Quality Engineers.
• Drive and implement process improvements across product lines and through quality systems plant wide.
• Provide QA support to Operations and to other support functions on quality to help achieve their objectives.
• Ensure regulatory compliance to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
• Monitor and implement appropriate statistical techniques to track performance.
• Preform internal quality audits.
• Manage customer complaints and define products validation requirements and protocols.
• Support the implementation of Lean Manufacturing across the site.

Job Requirements

• Level 8 in Engineering or Science related degree.
• Excellent people management and communication skills.
• A problem-solver with excellent analytical skills.
• Goal and target
• An ability to work in a fast-paced
• Minimum 4 years in Med Devices or Pharmaceutical manufacturing industry.

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

An exciting career opportunity awaits with a global medical devices company based in Cork for a Supplier Quality Engineer on a 12 months' contract.

Job Responsibilities of Supplier Quality Engineer:

• Providing engineering support for activities related to supplier selection and evaluation.
• Contributing to the development, maintenance and improvements of supplier quality policies and procedures.
• Reviewing and approving all material and component specification drawings.
• As a Supplier Quality Engineer you will be assessing supplier capabilities through direct visits, technical discussions and quality system audits.
• Contributing to and participating in Material Review Boards & supplier performance reviews.
• Evaluating and establishing Supplied Data Agreements with suppliers.
• Working with product line engineering to assess and address material quality issues.
• Demonstrating a thorough understanding of related quality standards, including ISO and GMP.
• As a Supplier Quality Engineer you will be assisting in establishing and implementing Supplier QA Department improvement goals.
• Evaluating in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Travel will be expected in this role.

Job Requirements:

• Bachelor’s Degree in relevant discipline (min Level 8)
• 2+ years experience in an Engineering / Quality role
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical and problem solving skills.
• Knowledge of Quality System Requirements
• Proven track record of working in a fast paced environment with strong technical capabilities
• Capable of handling multiple development aspects of assigned projects

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Validation Engineer (Pharma)

Looking to join a well-established pharmaceutical company? One of Ireland’s leading healthcare companies is looking for a Validation Engineer to join their team on an 11-month contract in Cork.  

Job responsibilities:

• Ensure highest Quality, Compliance and Safety standards primarily Technical/ Validation activities
• Project validation support including conducting equipment performance qualifications (cleaning and sterilization validation periodic reviews, re-qualifications, temperature mapping)
• Authoring project validation master plans, SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data
• Experience with audits and preparation for audits
• Technical review, ownership of and approval of Global Change Management records as required

Job requirements:

• Minimum 2 years validation experience
• Hons Degree or Masters in a Science or Engineering discipline
• Preference for Lean Six Sigma qualifications

If you would like to discuss this job, please reach out to Louise Whitty on 021 2359140 /

lwhitty@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

An exciting career opportunity awaits with a global medical devices company based in Cork for a Supplier Quality Engineer on a 12 months' contract.

Job Responsibilities of Supplier Quality Engineer:

• Providing engineering support for activities related to supplier selection and evaluation.
• Contributing to the development, maintenance and improvements of supplier quality policies and procedures.
• Reviewing and approving all material and component specification drawings.
• As a Supplier Quality Engineer you will be assessing supplier capabilities through direct visits, technical discussions and quality system audits.
• Contributing to and participating in Material Review Boards & supplier performance reviews.
• Evaluating and establishing Supplied Data Agreements with suppliers.
• Working with product line engineering to assess and address material quality issues.
• Demonstrating a thorough understanding of related quality standards, including ISO and GMP.
• As a Supplier Quality Engineer you will be assisting in establishing and implementing Supplier QA Department improvement goals.
• Evaluating in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Travel will be expected in this role.

Job Requirements:

• Bachelor’s Degree in relevant discipline (min Level 8)
• 2+ years experience in an Engineering / Quality role
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical and problem solving skills.
• Knowledge of Quality System Requirements
• Proven track record of working in a fast paced environment with strong technical capabilities
• Capable of handling multiple development aspects of assigned projects

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.