Senior Process Leadership Role
This is a key leadership position within the Engineering Team, accountable for overseeing the lifecycle of process equipment and validation at our Dundalk site.
Main Responsibilities:
1. Contribute to site strategy, operational planning, and cross-functional decision-making as a member of the Engineering Team.
2. Develop and execute the Process Equipment & Validation strategy, aligned with global engineering standards.
3. Lead efforts to embed a compliance-first, customer-focused culture and integrate engineering deliverables into commercial manufacturing operations.
4. Oversight of process equipment and validation activities from project initiation to commissioning, qualification, requalification, revalidation, and retirement.
5. Ensure technical and compliance governance for validated systems including process equipment, cleanrooms, utilities, laboratory systems, cleaning validation, thermal mapping, and computerised systems.
The ideal candidate will have a proven track record in establishing, developing, and scaling Process Engineering/Validation functions in biotech environments. They will be an expert in process equipment and validation lifecycle management within regulated biotech/biologics environments.
About This Opportunity
This role offers the chance to make a significant impact on the success of our Engineering Team. As a senior leader, you will be responsible for driving process excellence and ensuring that our manufacturing operations are compliant with regulatory requirements.
What We Are Looking For
* A highly experienced Process Engineer or Validation Specialist with a strong background in regulated biotech/biologics environments.
* Proven ability to develop and execute strategic plans, drive process improvements, and lead cross-functional teams.
* Excellent communication and interpersonal skills, with the ability to work effectively with stakeholders at all levels.
* Detailed knowledge of cGMP regulations and guidelines.
How You Will Make a Difference
You will play a critical role in shaping the future of our Engineering Team and contributing to the success of our organisation. Your expertise and leadership skills will help us to deliver high-quality products to our customers while maintaining the highest standards of safety, quality, and compliance.