Senior Process Engineer

Asset Recruitment; Swords; Hybrid; CAD 80,000 - 100,000; Full time

Job summary

A leading multinational Pharmaceutical company in Swords is seeking a Senior Process Engineer for a 6-month contract. The role involves leading investigations, supporting process improvements, and providing technical guidance across multiple projects in a dynamic environment.

Qualifications

• 6+ years operational support in Biopharma industry.
• Experience with Upstream processing and troubleshooting.

Responsibilities

• Lead investigations and ensure effective Root Cause Analysis.
• Support industry 4.0 initiatives and data analytics.
• Provide technical guidance to process engineering team.

Skills

Collaboration

Project Management

Communication

Troubleshooting

Education

Degree in Science, Engineering, or Technical

Job description

ref. 01288

Senior Process Engineer

Exciting opportunity for a Senior Process Engineer with our client, a leading multinational Pharmaceutical company based in Swords.

This role provides an exciting opportunity to work on multiple projects, ranging from manufacturing support activities to new product introductions and technology transfers to regulatory submissions. The role will deliver a diverse range of technical expertise and support to the Business.

This is a 6 Months contract position.

Responsibilities

• Lead, assist in and facilitate investigations, ensuring effect Root Cause Analysis and CAPAs, data analysis and interpretation to resolve complex cell culture deviations.
• Lead process improvement and troubleshooting with end-to-end product focus.
• Support the industry 4.0 initiative to navigate operations and data analytics in a digital environment.
• Author and review batch documentation, technical reports and supporting global regulatory submissions as needed.
• Provide technical support to new process introduction or change implementation in commercial manufacturing operations.
• Provide technical guidance to members of the process engineering team and IPT
• Support execution, data analysis and interpretation of trends observed in commercial process monitoring (e.g., proactive process analysis, continued process verification, statistical process control, multivariate analyses)
• Lead and/or support various site initiatives to improve compliance status and overall operational efficiency of the site
• Lead and/or support the execution of development and PPQ batches
• Resolve issues and identify risks in a timely manner.

What skills you will need:

To excel in this role, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams
You will more than likely have experience in:
• Proven ability in collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site
• Strong project management, verbal and written communication skills
• Strong Experience with Upstream processing and troubleshooting including Tech Transfer, regulatory filing, and commercial manufacture
• Experience in leading complex investigations and in supporting regulatory inspections

Requirements
• This role requires an experienced individual with a Degree (or higher) in Science, Engineering, Technical or equivalent
• 6+ years operational support (or 4+ years Tech Support) in Biopharma industry, with direct experience of USP biologics manufacture, facility commissioning, qualification, validation and startup