Process Engineer Specialist Tech Transfer NPI

Job Description

Process Engineer Specialist - Tech Transfer NPI

New exciting opportunities now exists on our Carlow Site for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager

Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. You will typically have prior related work experience; ideally in manufacturing preferably GMP Setting but we will consider applicants from other working environments as long as they have technology transfer experience

Knowledge of process monitoring systems automation systems (DeltaV) operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity for this role

Our Engineers support internal and external manufacturing operations remain operational continuously improve and innovate. With our extensive range of facilities and environments our Engineers have opportunities across many diverse areas including Biological Chemical Automation Capital Projects Maintenance Safety Process Development Technical Services Utilities and Validation.

What you will do:

Bring energy knowledge innovation and leadership to carry out the following:

• Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process
• Design/Author/Review/Approve/Execute Execution/development of change controls
• Contribution to Kaizen events as appropriate
• Technical input into quality notification by authoring/reviewing/approving investigations
• Execution of equipment/qualification validation programs; including re-qualification and re-validation
• Support continuous improvement through Lean Six Sigma methodologies
• Perform root cause analysis of system failures substandard performance using standard tools and methods to resolve machine and system issues
• Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow 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 action participate in audits and inspections and proactively highlighting any issues around compliance
• Work collaboratively to drive a safe and compliant culture in Carlow
• 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:

• Bachelors Degree or higher preferred; ideally in a Science Engineering or other Technical discipline
• Min 3 years experience ideally in manufacturing preferably GMP Setting
• Demonstratable experience of leading technical related projects
• Evidence of continuous professional development is desirable
• Knowledge of process monitoring systems automation systems (DeltaV) operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity
• 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
• Excellent communication presentation and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team orientated manner

At our company we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. Were always looking to make a difference for people patients and communities from Ireland to the world.

Required Skills:

Preferred Skills:

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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