Job Title : Process Engineer
Location : Waterford, County Waterford
Company : Horizon
Salary :
Open Date : 2023-04-12
Close Date : 2023-08-12
At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us. The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees’ personal and professional lives. 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.

Our Values

• Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
• Accountability: We do what’s right for our patient communities through quality decisions and owning our successes and failures.
• Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.

These three values come to life through our five Leadership Expectations that apply to all Horizon employees

• Enterprise Mindset: Look beyond one’s team, brand or function to see the broader company and external perspective
• Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
• Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
• Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
• Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their role

At Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better. Horizon Therapeutics plc is an equal opportunity employer. Horizon will consider all qualified applicants for employment without regard to any characteristic protected by applicable law.

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