Senior Process Engineer

PE Global; Swords; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading biotech company is seeking a Senior Process Engineer to join their Manufacturing, Science & Technology team. This role involves supporting upstream manufacturing and leading process improvement initiatives. The successful candidate will have a strong background in biopharma and regulatory requirements, with opportunities to work on diverse projects.

Qualifications

• Minimum 6 years operational support in Biopharma industry.
• Strong experience with Upstream processing and troubleshooting.

Responsibilities

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

Skills

Process Improvement

Technical Support

Data Analysis

Troubleshooting

Education

Degree in Science or Engineering

Job description

Direct message the job poster from PE Global

Senior Recruitment Consultant @ PE Global | Recruitment Consultant Science & Engineering

The role:

PE Global is currently recruiting for a Senior Process Engineer (MS&T) on behalf of a leading biotech company based in Dublin North. This is an initial 6-month contract role.

Job Purpose:

A new position has arisen in our growing Manufacturing, Science & Technology (MS&T) team for a Senior Process Engineer to support Upstream Manufacturing.

This role provides exciting and interesting opportunities 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.

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

Education and Experience:

• 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
• 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

Interested candidates should submit an updated CV.

Please click the link below to apply, call Niamh on 0832033710 or alternatively send an up to date CV to [e-mail]

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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