Process Engineer

Job Description

We are hiring aProcess Engineer / Specialistto join theTech Ops Commercial Support Process teamat ourCarlow site. This is an exciting opportunity to work in a biopharma manufacturing environment supportingcommercial products commercialisation activities and process improvement initiatives.

This role is well suited to an experienced independent engineer who canhit the ground running act as atechnical SME and work across a wide range of stakeholders. You will have visibility across site above site and global teams with opportunities to contribute to business-critical projects stretch assignments and continuous development.

Role Responsibilities

• Coordinate execute and documentqualification process studies and related product programmes.

• Provide technical support forcommercial manufacturing includingtechnical impact assessments.

• Own and managechange controlsand related compliance commitments.

• Performdata analysisusingPDM/DataLynxand other relevant systems to support process understanding and decision-making.

• UseMES Pi and automation systemsto monitor control and optimise process performance.

• Conduct and supportQuality Risk Assessments (QRA)in line with site and corporate standards.

• Support and maintainCPV (Continued Process Verification)andPPM (Proactive Process Monitoring)systems to ensure ongoing process performance and product quality.

• Ensureaudit readiness including preparation documentation and interaction with auditors.

• Generate review and approve process documentation in line withcGMP QMS and regulatory requirements.

• Lead and supportinvestigations troubleshooting and deviation resolution.

• Represent Technical Operations in cross-functional meetings and provide technical expertise as required.

• Ensure compliance withQMS and relevant standards proactively identifying and escalating compliance risks.

• Drivecontinuous improvementusingMPS / Lean toolsand contribute to problem-solving and project work.

• Lead business-critical projects and process initiatives for Technical Operations.

• Demonstrate strong communication and teamwork to support a safe compliant and high-performing culture.

• Continuously develop technical capability and provide mentoring/guidance where appropriate.

• Apply understanding of key business drivers to day-to-day activities.

• Perform other duties as required.

What skills you will need

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

• ABachelors degree or higherinScience Engineering or another technical discipline.

• 45 years experiencein a manufacturing environment preferablyGMP with experience inaseptic manufacturing and/or process engineering.

• Demonstrated experience in:

  • Managingchange control projects

  • Completingtechnical impact assessmentson commercial products

  • Performingdata analysisusingPDM/DataLynx and presenting findings to site and global functions as required

  • Working withMES Pi and automation systems

  • Supporting/ leadingQRA

  • SupportingCPV and PPM systems

  • Maintainingaudit readiness

• Strong knowledge of relevantIrish European and international regulatory requirements codes and standards.

• Excellenttechnical writingskills including reports standards policies and protocols.

• Familiarity withsterile filling processes and equipment.

• Proficiency inMicrosoft Officeand other job-related applications.

• Strongcommunication presentation and interpersonal skills with the ability to work effectively across all levels and with external partners.

• Experience withLean Six Sigmamethodology is preferred.

The following would be advantageous:

• Experience withdata analytics systems

• Knowledge ofQRMand integrated risk management

• Background infill-finish / sterile injectables

• Experience withMES / SAPand deviation management systems

• Experience drafting protocols inKneat / similar system/s

• Experience inmedical devicesmay also be considered if the required skills are met

Our facility in 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.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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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