Spclst, Engineering

MSD Malaysia; Carlow; Hybrid; EUR 85,000 - 110,000; Full time

Job summary

MSD is seeking an Engineering Specialist (Validation) for its Carlow site in Ireland. The role supports Cleaning Validation & Recovery teams in a cGMP setting, delivering qualification/validation activities and change controls.

You will liaise with Production, Maintenance and Quality, drive continuous improvement, and participate in audits and regulatory submissions as needed. The successful candidate will have strong validation experience, knowledge of DeltaV/Pi System, and a proven track

Qualifications

• Relevant technical qualification in pharmaceutical/biological/chemical sciences or engineering.
• Proven track record delivering validation/execution in cGMP environments.
• Experience with Tank CIP and Parts Washers in-process components.
• Experience with cleaning recovery studies and TOC/swab methods.

Responsibilities

• Design/author/review/approve/execute qualification/validation docs and cycle development.
• Design/author/review/approve/execute change controls.
• Resolve technical issues during study execution.
• Collaborate with Production, Maintenance and Quality during Cycle Development & PQ.
• Provide technical input for investigations and quality notifications.
• Perform root cause analysis on system failures and performance issues.
• Support Lean Six Sigma continuous improvement initiatives.
• Represent validation in cross-functional projects and global forums.
• Ensure compliance with GMP and regulatory requirements in daily activities.
• Maintain documentation, risk assessments, and corrective actions; support audits.
• Assist regulatory audits and submissions as required.
• Promote a safe, compliant culture on site; perform other duties as assigned.

Skills

Validation expertise

CGMP knowledge

Project management

Data analysis

Communication skills

Education

Applied Pharmaceutical/ Biological/ Chemical sciences degree

Tools

DeltaV

Pi System

MS Office

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

In order to excel in this role, you will more than likely have:

• 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. Please feel free to speak to us about what flexibility means to you during your application.

Required Skills

Biopharmaceutical Operations, Change Control Processes, Deviation Management, Standards Compliance, Sterile Processing, Technical Project Management, Technology Transfer

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.