Process Engineer

Job Description

On behalf of Horizon Therapeutics, we are currently seeking a Process Engineer to join their Waterford manufacturing site on a permanent basis.

Position Summary:

The Process Engineer is a key role within the MSAT team working alongside Sterile Fill Finish Drug Product operations and other supporting functions. The position supports Horizon's strategic vision as a multi-product manufacturing site, by actively working with various NPI Teams to ensure that processes fit within the plant, and timelines are met. The position is responsible for facilitating the technology transfer, development, and manufacturing of innovative biologic products into Horizon Waterford

Responsibilities:

• Provide process engineering support to Sterile Fill Finish product teams and projects
• Performing gap analysis, facility fit assessments, process gap assessments and risk analysis for new product introductions.
• Develop and support new manufacturing processes and technologies
• Development of tech transfer-related documents e.g., Tech Transfer Plans/Protocols/Procedures/Manufacturing Batch Records.
• Development of critical process parameters, process capability analysis and deviation monitoring
• Providing operational technical support for process-related issue resolution.
• Define and review equipment specifications and associated test documentation.
• Support project delivery through FAT, SAT and IOQ as needed
• Strong focus on disciplined root cause analysis
• Liaise with vendors on single-use technologies and integration into the process * Monitor process risk and ensure mitigations are in place as required
• Benchmark other industries and organizations to ensure best practice is in use.
• Be active in the network, attending conferences/training seminars as needed Health, Safety and the Environment
• Always comply with the Health, Safety and Environmental policy and associated procedures.
• Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do. Quality Compliance
• Ensure all work carried out, complies with the required standards, conforming to company, cGMP, cGLP, SOP's and regulatory guidelines.
• Take ownership of quality compliance in all activities under the responsibility of the role Qualifications and Skills Required:
• Qualified to a minimum Degree level in engineering or a related discipline
• Minimum 8 years of Process Engineering / Technical Services experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment)
• cGMP compliance
• Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem-solving techniques
• Ability to understand engineering processes through a logical, data-driven, hands-on approach
• Use of FMEA, FMECA and Risk assessment techniques
• Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective
• Proficient in Microsoft Office.
• Professional, proactive demeanour.
• Strong interpersonal skills.
• Excellent written and verbal communication skills.