Spclst, Engineering

Merck; Ireland; Hybrid; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Hybrid working model

State-of-the-art facilities

Job summary

Merck in Ireland seeks an Engineering Specialist (Validation) to join the Cleaning Validation & Cleaning Recovery teams in a cGMP environment. You will design, author, review and execute qualification studies, and contribute to change controls while resolving technical issues and driving continuous improvement using Lean Six Sigma methodologies.

The role requires collaboration with Production, Maintenance and Quality, and participation in audits and regulatory submissions.

Qualifications

• Relevant technical qualification in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
• Experience in validation of Tank CIP & Parts Washer for in-process components.
• Experience in cleaning recovery studies using TOC and swab methods.
• Change控制/Deviation management experience.
• Demonstrable experience leading technical projects.
• Knowledge of GMP regulatory requirements.

Responsibilities

• Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development.
• Design/Author/Review/Approve/Execute execution/development of change controls.
• Perform root cause analysis of system failures and resolve issues.
• Engage with Production, Maintenance and Quality during Cycle Development & PQ activities.
• Support regulatory audits and submissions as required.
• Drive compliance with cGMP and global policies.

Skills

Qualification leadership

Tank CIP validation

Cleaning recovery studies

Change control management

Root cause analysis

Lean Six Sigma

Regulatory awareness

Documentation & reporting

Process monitoring systems

Automation tools (DeltaV)

Education

Applied Pharmaceutical/Chemical/ Biological science or Engineering qualification

Tools

DeltaV

Pi System

Office software

Job description

Job Description

A fantastic opportunity has arisen for an Engineering Specialist (Validation). This opportunity is for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidate will support the Cleaning Validation & Cleaning Recovery Teams.

Bring energy, knowledge, innovation to carry out the following:

• Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
• Design/Author/Review/Approve/Execute Execution/development of change controls.
• Resolving technical issues encountered during study execution.
• Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
• Technical input into quality notification by authoring/reviewing/approving investigations.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
• Support continuous improvement through Lean Six Sigma methodologies.
• Serve as validation representative for cross functional projects and represent the validation team at global technical forums
• 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 actions, participation in audits and inspections and proactively highlighting any issues around compliance
• Supporting regulatory audits and submissions as required.
• Work collaboratively to drive a safe and compliant culture on site.
• May be required to perform other duties as assigned.

What skills you will need:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
• Experience in the validation of Tank CIP & Parts Washers for in-process components.
• Experience in cleaning recovery studies using TOC and swab methods.
• Exception / Deviation Management and Change Control.
• Demonstratable experience of leading technical related projects.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
• Evidence of continuous professional development is desirable.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile Fill-Finish processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications required
• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
• Equipment Periodic Validation
• Equipment Validation Lifecycle
• Project Management Skills/Qualification
• Autoclave/SIP Sterilisation Validation
• Dry Heat Sterilisation
• Isolator VHP/HVAC Qualification
• Controlled Temperature Units/Equipment Qualification
• Vial and Syringe Processing Technologies

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing talented and committed people together.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Required Skills:

Biopharmaceutical Operations, Change Contr