Spclst, Engineering

MSD Malaysia; Ireland; Hybrid; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid working model

Job summary

MSD Malaysia is seeking an Engineering Specialist (Validation) to support Cleaning Validation & Recovery teams in a cGMP environment. The role is based at the Carlow site with a new hybrid working model.

You will design, execute and review qualification/validation documentation, lead change controls, perform root cause analysis, and drive continuous improvement while collaborating with Production, Maintenance and Quality teams.

Qualifications

• Technical qualification in applied pharmaceutical/engineering fields with proven delivery of validation/execution.
• Experience validating Tank CIP & Parts Washers and cleaning recovery studies.
• Excellent documentation, change control and deviation management skills.

Responsibilities

• Design, author, review, and execute qualification/validation documents and cycle development.
• Develop and execute change controls and investigations with robust RCA.
• Collaborate with Production, Maintenance and Quality during Cycle Development & PQ activities.
• Support regulatory audits/submissions and ensure cGMP compliance daily.
• Drive continuous improvement using Lean Six Sigma methodologies.
• Represent validation in cross-functional projects and global technical forums.

Skills

Validation experience

cGMP knowledge

Lean Six Sigma

DeltaV automation

Root cause analysis

Education

Biopharmaceutical / chemical sciences degree

Engineering qualification

Tools

DeltaV

PI System

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.