Senior Process Engineer

Life Science Recruitment; Swords; Hybrid; CAD 80,000 - 110,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking a Senior Process Engineer for a 6-month hybrid contract. The role involves leading investigations, supporting regulatory submissions, and driving process improvements within a dynamic team. Candidates should have a degree and at least 6 years of experience in process engineering, particularly in the biopharma industry.

Qualifications

• Minimum 6 years operational support in Biopharma industry.
• Experience in leading complex investigations and supporting regulatory inspections.
• Working knowledge of current regulatory requirements and Good Manufacturing Practices.

Responsibilities

• Lead investigations and ensure effective Root Cause Analysis.
• Support industry 4.0 initiatives and provide technical guidance.
• Author and review batch documentation and technical reports.

Skills

Upstream processing

Troubleshooting

Regulatory filing

Data analysis

Process improvement

Education

Degree in Science, Engineering, Technical or equivalent

Job description

Senior Process Engineer - Tech Transfer

Hybrid - Swords

6 month contract

AMC23231

I am currently looking for a Senior Process Engineer with New Product introduction experience for an new exciting project with a biopharmaceutical client in North Dublin.

This role provides opportunities to work on multiple projects, ranging from manufacturing support activities to new product introductions and technology transfers to regulatory submissions.

If you have a bachelors degree and at least 6 years experience working in Process Engineering in a pharmaceutical environment including Tech transfer or New product introduction this could be the role for you!

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.
• Provide technical support to new process introduction or change implementation in commercial manufacturing operations.
• Author and review batch documentation, technical reports and supporting global regulatory submissions as needed.
• 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 fashion. Ensure project milestones are achieved through planning and execution of integrated overall program schedule

Requirements

• Strong Experience with Upstream processing and troubleshooting including Tech Transfer, regulatory filing, and commercial manufacture
• Experience in leading complex investigations
• Experience in supporting regulatory inspections
• Working knowledge of current regulatory requirements and current Good Manufacturing Practices
• This role requires an experienced individual with a degree (or higher) in Science, Engineering, Technical or equivalent
• Minimum 6 years operational support (or 4 years plus Tech Support) in Biopharma industry, with direct experience of USP biologics manufacture, facility commissioning, qualification, validation and startup

Apply today or get in touch with Angela McCauley from Life Science Recruitment for more information.