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MSD Ireland

Validation Engineer Job

MSD Ireland

  • Carlow
  • Negotiable
  • Permanent full-time
  • Updated 02/01/2013
  • Merck
this job is expired
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Description

Validation Engineer Job

 

Validation Engineer-ENG002435

Description

Job Purpose: Co-ordinate and execute equipment qualification and validation as required and participate in Cleaning, PPQ, Filter, CCI, E&L, Shipping and additional validation programs where applicable. Develop a high level of technical expertise across a range of different equipment/processes/products. Ensure that objectives are effectively achieved, consistent with Merck's requirements to ensure compliance, safety and reliable supply to our customers

Principal Accountabilities:

- Coordinate work flow to ensure target achieved; including vendor management, resource allocation and communications. Provide logic and input into project schedules. Support and participate in the technical transfer process.
- Develop and drive an understanding of the importance of compliance, considering an impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, review of protocols and reports, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
- Accountable to format, write, deliver and review necessary qualification/ validation documentation in line with the standard approval process, and facilitate others to do so. Be a document system expert; this will include document review, approval and document system work flow expedition.
- Execution of equipment/qualification validation programs, using Lean Six Sigma methodologies to ensure continuous improvement. Actively participate in heat penetration/distribution studies associated with cycle development and PQ using Kaye thermal system and biological challenges.
- Co-ordination and support of the execution cleaning validation and process performance qualification programs.
- Perform data analysis and determine conclusions reached; facilitating others to do so; make informed decisions/recommendations around conclusions reached from data analysis, using Lean Six Sigma methodologies as appropriate.
- Support and execute the re-qualification program.
- Support continuous improvement by leading and active participation in projects, system failure investigations and investigation reports, execution/development of change control, and 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. Serve as technical Operation representative for internal technical group discussions and represent technical Operations Carlow at global technical forums.
- Required to comply with Merck 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.
- Work collaboratively to drive a safe and compliant culture in Carlow.
- May be required to perform other duties as assigned.

Qualifications

Bachelors Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline

Considerable experience and critical skills in their area of expertise that add value to the business; ideally in a 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
- Lean Six Sigma Methodology experience desired
- Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner

*LI-SC1

Job: Engineering Generic

Job Title: Validation Engineer

Primary Location: EMEA-IE-Leinster-Carlow

Employee Status: Regular

Number of Openings: 1

External Job Board Posting: Ireland - IrishJobs.ie

To apply for this position please click here

Ref: ENG002435-en_US_1356825680
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MSD Ireland

MSD Ireland

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