Senior Process Engineer

Orion Engineering Services Limited; Swords; On-site; CAD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Process Engineer to join a diverse team in the Biopharmaceutical sector. This role involves leading investigations, supporting regulatory compliance, and driving continuous improvement initiatives. The ideal candidate will have a strong background in upstream processing, project management, and regulatory requirements, with a commitment to fostering an inclusive workplace. If you are passionate about innovation and eager to make a significant impact in a dynamic environment, this opportunity is perfect for you.

Qualifications

• 6+ years in operational support in the Biopharma industry.
• Experience with upstream processing and regulatory compliance.

Responsibilities

• Lead investigations and facilitate root cause analysis.
• Support industry 4.0 initiatives and data analytics.
• Provide technical guidance to process engineering teams.

Skills

Collaboration Skills

Cross-Functional Leadership

Project Management

Verbal and Written Communication

Change Management

Data Analysis

Troubleshooting

Regulatory Compliance

Education

Degree in Science, Engineering, or Technical Field

Job description

Orion Group Life Sciences are currently recruiting a Senior Process Engineer on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 6-Month contract with potential to extend.

Working with a multi-functional, diverse team to deliver results within schedule, you will bring your energy, knowledge, and innovation to:

• 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

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
• Proven ability to effectively initiate and drive change across the site
• Strong verbal and written communication skills, project management skills
• 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

Minimum Education/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
• Working knowledge of current regulatory requirements and current Good Manufacturing Practices

Our role in supportingdiversityandinclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.