This role as a Manufacturing Technician for tech transfer and new product introduction (NPI) in pharmaceutical manufacturing is a dynamic position that bridges the technical and operational aspects of producing drug products. Here’s a summary to guide you in understanding key elements of the role and how your qualifications and skills may align with these responsibilities:
Key Responsibilities and Focus Areas

The role is structured around three main functional areas:

• Manufacturing Execution:
• Preparation and Production: Handling the full manufacturing lifecycle for both small and large molecule drug products, including clinical, non-clinical, and pre-clinical material production. Tasks such as batch preparation, aseptic compounding, sterile filtration, and filling are essential to ensure product quality and compliance.
• Cleanroom Operations: Working within a cleanroom environment, you will manage environmental monitoring, equipment sterilization (e.g., autoclaving), and adherence to GMP standards.
• Single Use Technologies: Collaborating with vendors to implement or refine these systems to enhance efficiency and reduce cross-contamination risks.
• Biologic Drug Product Support:
• Support the commercial manufacturing process by ensuring readiness for regulatory compliance, quality testing, and successful integration of new production campaigns.
• Assist in multi-product suite operations, where the capability to switch between different product lines seamlessly is key.
• New Product Introduction (NPI) and Project Management:
• Engage in cross-functional project teams, collaborating with R&D, Quality, Supply Chain, and other departments.
• Participate in technical documentation reviews and contributions, ensuring that manufacturing protocols, batch records, and reports are accurate and aligned with GMP standards.
• Project involvement includes working toward tech transfer goals, such as introducing a new manufacturing process, qualifying equipment, and improving manufacturing workflows.

Required Skills and Qualifications

To succeed in this position, the following background and skills are essential:

• Educational and Professional Background:
• Ideally, candidates have a 3rd-level qualification in a related field (e.g., Pharmaceutical Science, Biotechnology).
• Experience: 12-18 months in pharmaceutical or medical device industries, particularly with exposure to cleanroom environments and aseptic techniques.
• Technical Skills:
• GMP Knowledge: Strong understanding of Good Manufacturing Practices and regulatory guidelines.
• Sterilization Techniques: Experience with autoclave operations, depyrogenation (removing pyrogens to ensure sterility), and filter integrity testing.
• Lyophilization (Freeze-Drying): Familiarity with freeze-drying processes, essential for preserving product stability in certain formulations.
• Single-Use Technology: Experience with single-use systems, which are becoming a standard in reducing contamination risk and facilitating product changeover.
• Soft Skills:
• Documentation and Compliance: Competent technical writing skills for preparing or reviewing protocols, reports, and GMP-compliant documents.
• Problem Solving and Proactivity: Ability to troubleshoot and resolve production issues, often proactively identifying improvements.
• Team Collaboration: Experience in cross-functional, project-based teamwork with excellent communication skills to effectively liaise across departments.

Additional Considerations

• Shift Flexibility: This role requires adaptability to a rotating 12-hour shift pattern, including days, nights, and weekend shifts, which is common in continuous manufacturing operations.
• EHS Adherence: Familiarity with Environment, Health, and Safety (EHS) policies to ensure a safe and compliant work environment.

Opportunities and Benefits
This position offers a clear career path, strong benefits, and work-life balance that may include further specialization in either biologics or project management. For individuals interested in broadening expertise in NPI and tech transfer in a highly regulated industry, this role is positioned well for growth into higher technical or management roles within pharmaceutical manufacturing.
This role requires a blend of technical skills and adaptability, with a strong emphasis on GMP compliance, cross-functional collaboration, and shift flexibility.
Job Types: Full-time, Permanent
Pay: €32,000.00-€50,000.00 per year

Schedule:

• Day shift
• Monday to Friday
• Night shift
• Weekend availability

Work Location: In perso

• Manufacturing Execution:
• Preparation and Production: Handling the full manufacturing lifecycle for both small and large molecule drug products, including clinical, non-clinical, and pre-clinical material production. Tasks such as batch preparation, aseptic compounding, sterile filtration, and filling are essential to ensure product quality and compliance.
• Cleanroom Operations: Working within a cleanroom environment, you will manage environmental monitoring, equipment sterilization (e.g., autoclaving), and adherence to GMP standards.
• Single Use Technologies: Collaborating with vendors to implement or refine these systems to enhance efficiency and reduce cross-contamination risks.
• Biologic Drug Product Support:
• Support the commercial manufacturing process by ensuring readiness for regulatory compliance, quality testing, and successful integration of new production campaigns.
• Assist in multi-product suite operations, where the capability to switch between different product lines seamlessly is key.
• New Product Introduction (NPI) and Project Management:
• Engage in cross-functional project teams, collaborating with R&D, Quality, Supply Chain, and other departments.
• Participate in technical documentation reviews and contributions, ensuring that manufacturing protocols, batch records, and reports are accurate and aligned with GMP standards.
• Project involvement includes working toward tech transfer goals, such as introducing a new manufacturing process, qualifying equipment, and improving manufacturing workflows