Senior Process Engineer

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

Job summary

A leading recruitment agency is seeking a Senior Process Engineer for a 6-month contract in Swords, Ontario. The role involves leading investigations, supporting new product introductions, and ensuring compliance with regulatory standards in a biopharmaceutical environment. Ideal candidates will have a bachelor's degree and significant experience in process engineering, particularly in the biopharma industry.

Qualifications

• Minimum 6 years of experience in Process Engineering within a pharmaceutical environment.
• Experience in Tech Transfer and New Product Introduction.

Responsibilities

• Lead investigations and ensure effective Root Cause Analysis.
• Support Industry 4.0 initiatives for enhanced operations.
• Provide technical support for new process introductions.

Skills

Problem Solving

Data Analysis

Root Cause Analysis

Education

Bachelor's Degree in Science or Engineering

Job description

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Contract Life Science Recruiter ~ CQV ~ Validation ~ QA ~ QPs

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 exciting project with a biopharmaceutical client in North Dublin.

This role offers opportunities to work on multiple projects, including manufacturing support, new product introductions, technology transfers, and regulatory submissions.

If you hold a bachelor’s degree and have at least 6 years of experience in Process Engineering within a pharmaceutical environment, including Tech transfer or New product introduction, this could be the role for you!

Responsibilities:

1. Lead, assist in, and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs, data analysis, and interpretation to resolve complex cell culture deviations.
2. Lead process improvement and troubleshooting with an end-to-end product focus.
3. Support the Industry 4.0 initiative to enhance operations and data analytics in a digital environment.
4. Provide technical support for new process introductions or change implementations in commercial manufacturing.
5. Author and review batch documentation, technical reports, and support global regulatory submissions as needed.
6. Provide technical guidance to the process engineering team and IPT.
7. Support data analysis and interpretation of trends in commercial process monitoring, including proactive process analysis, continued process verification, statistical process control, and multivariate analyses.
8. Lead or support site initiatives to improve compliance and operational efficiency.
9. Support the execution of development and PPQ batches.
10. Identify and resolve issues and risks promptly, ensuring project milestones are met through integrated planning and execution.

Requirements:

1. Strong experience in upstream processing and troubleshooting, including Tech Transfer, regulatory filing, and commercial manufacturing.
2. Experience leading complex investigations.
3. Experience supporting regulatory inspections.
4. Working knowledge of current regulatory requirements and GMP standards.
5. Degree (or higher) in Science, Engineering, Technical field, or equivalent.
6. Minimum 6 years of operational support (or 4+ years of technical support) in the biopharma industry, with direct experience in USP biologics manufacturing, facility commissioning, qualification, validation, and startup.

Apply today or contact Angela McCauley from Life Science Recruitment for more information.