Senior Packaging Process Engineer

Eirgen Pharma; Munster; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Health insurance

Pension

Social club

Canteen facilities

Job summary

Eirgen Pharma in Munster is seeking a Senior Packaging Process Engineer to provide process engineering support and project leadership. In this role, you'll focus on quality compliance, safety, and process improvements in the packaging department.

The ideal candidate will possess a degree in Engineering and have over 5 years of experience in GMP packaging environments. Excellent benefits are offered, including pension and health insurance.

Qualifications

• 5+ years of engineering experience working in a GMP packaging environment.
• Experience in process validation and statistics is an advantage.

Responsibilities

• Provide process engineering support for packaging projects.
• Lead procurement and qualification of process equipment.
• Ensure compliance with quality standards and regulations.
• Manage process improvements and validation activities.

Skills

Process validation

GMP packaging experience

Problem solving

Statistical analysis

Education

Degree in Engineering discipline

Job description

Senior Packaging Process Engineer

Reach your career goals with Eirgen Pharma, your future could be here!

About Eirgen Pharma

Would you like to be part of a company that has the courage, innovation, and capability to improve and enhance patient lives across the globe?

Founded in 2005, Eirgen Pharma employs over 180 people in Waterford. We combine the agility of a small company with the ambition to deliver high-quality medicines globally — all within a collaborative, people-focused culture.

About this Opportunity

You will provide process engineering support and project leadership to support internal customers in the day to day operations of the organization and site capital projects, enabling delivery of high quality process centered projects safely, on time and within budget with a specific focus on our packaging requirements.

Key Responsibilities:

Health & Safety

• Comply at all times with the Health, Safety and Environmental policy and associated procedures, legislative requirements.
• Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
• Ensure safety management is paramount in project delivery processes
• Lead by example and take ownership of EHS matters in relation to engineering activities you are involved in.

Quality Compliance

• Ensure all work carried out is in compliance with the required standards, conforming to company policy, cGMP, SOP and regulatory guidelines.
• Lead by example and take ownership for quality compliance in relation to engineering activities you are involved in.
• Ownership of equipment qualification and process validation from a quality compliance perspective.

Process Engineering

• Identify and manage process improvements and projects
• Lead in the procurement, introduction, commissioning and qualification of process equipment and subsequent process validations
• Ensure qualification methodology is clear and integrated into the project from URS onwards
• Ensure documentation, training and handover meet the internal customers’ expectations
• Life cycle cost considered in designs for maximum long term efficiency and reliability
• Plan and execute process validation schedules for packaging processes.
• Write and execute documents for the validation of new and existing processes.
• Liaise with contractors/customers when external resources are required to complete validations.
• Liaise with relevant Eirgen departments to organise resources/materials/ equipment/facilities/etc and ensure validation activities are planned and executed in line with applicable deadlines.
• Assist with submission/audit/deficiency responses activities when required, in a timely manner.
• Draft/revise/review validation related documents e.g. SOPs, protocols, reports etc.
• Generate, analyse and interpret statistical data to verify acceptable criteria has been met and support process validations, CPVs
• Develop testing strategies and rationale for manufacturing and packaging process equipment qualification and process validation.
• Provide technical support/troubleshooting for process and equipment issues.
• Investigate/resolve deviations associated with validation activities.
• Utilise structured problem solving in support of process issues & problem resolution.

Contractor Coordination

• Ensure contractors are budgeted, approved, scheduled, qualified and permitted for the work they perform under your behest
• Develop relationships with contractors, ensure they understand our business and are compliant to site procedures

Reporting and Governance

• Report covering schedule, cost control, project scope and risks / mitigations, compiled at appropriate intervals
• All project and equipment related information stored centrally
• Ensure clear, concise communications with internal & external stakeholders

About you

• Qualified to a minimum of degree level in an Engineering discipline
• 5+ years’ engineering experience working in a GMP packaging (or comparable) environment
• Process validation (including statistics training) experience is an advantage

Why Join Eirgen Pharma?

• You will work as part of a collaborative analytical team, contributing to high-quality data delivery in a fast-paced, GMP-regulated environment
• Opportunity to work on development-stage and commercial products
• Collaborative and quality-driven environment
• Excellent benefits, pension, health insurance, social club, canteen facilities

Apply for the above role by sending your CV to [e-mail] including the job title in the subject.