Senior Biopharmaceutical Tech Transfer and NPI Engineer - 11 month Hybrid Contract, Carlow. Ireland.
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Please note experience in Product Tech Transfer and New Product Introduction is essential to proceed with this job application
Job Description:
We are seeking a dynamic and ambitious Technical Engineering professional for this role. The successful candidate will be pivotal in the development of our drug product facility, focusing primarily on process tech transfer and new product introduction. The successful candidate will lead validation programs, provide technical support, and drive process improvement projects. Collaboration across functions and coaching project sub-teams are essential to meet project schedule milestones in accordance with the company's standards for Quality and EHS compliance.
Key Responsibilities:
1. Safety: Promote a safe and compliant culture, collaborating with multiple partners to achieve excellence in technical transfer programs.
2. Compliance: Ensure adherence to the company's policies, procedures, guidelines, and regulatory requirements. Execute current Good Manufacturing Practices (cGMP) in daily activities.
3. Process Engineering & Validation: Lead and execute process engineering and validation activities to support technical transfers and new product introduction.
4. Projects: Manage multiple technical engineering projects, including process improvements, capital projects, and Lean projects. Lead integrated project teams to deliver project business cases.
5. Continuous Improvement: Manage and deliver on technical/validation/quality notifications/change control/project support. Foster Lean Six Sigma and standard work within the technical engineering team.
6. Technical Expertise: Act as a subject matter expert on equipment design, C&Q execution and planning, process design, and validation. Liaise with global engineering services and specialist vendors.
Qualifications & Experience:
* Considerable experience in a comparable role, with process engineering and/or validation experience in a sterile manufacturing environment.
* Proven track record in leading technical teams through sustaining operations and technical transfer projects.
* Strong career history in biopharma (ideally aseptic filling) and familiarity with a highly regulated environment.
* Innovative thinker with excellent decision-making and problem-solving skills.
* Experience in applying Six Sigma and Lean methodologies.
* Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
* In-depth knowledge of sterile filling processes and equipment, especially aseptic processing.
* Experience in audit preparation and execution.
* Strong data analysis capability and proven record of process improvement implementation.
* Degree qualification or equivalent (Science, Engineering, Technical). Green Belt preferable.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Engineering and Information Technology
* Pharmaceutical Manufacturing
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