We're currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Mayo. This is a permanent, full-time position working 12-hour shifts on a monthly rotating schedule.

Ideal Background:

This role likely requires experience in pharmaceutical or biopharmaceutical manufacturing, specifically in sterile production environments. A background in biotechnology, pharmaceutical sciences, engineering, or a related field, along with knowledge of GMP, would be essential. Certifications related to aseptic processing, environmental monitoring, or EHS standards would be advantageous.

Key Responsibilities:

• Overseeing the production of materials at various stages of the product lifecycle (clinical, non-clinical, and pre-clinical stages).
• Handling batch preparation activities such as vial washing, load sterilization, and area preparation for production.
• Performing activities in accordance with the required cleanliness classification of the production area (e.g., sterile, Grade A, or other).
• Carrying out sterile operations such as compounding, sterile filtration, and sterile filling.
• Working with external vendors to help develop or improve systems related to single-use technologies, ensuring their effective integration into the manufacturing process.
• Preparing components, tools, and equipment for processing into Grade A environments, ensuring the highest levels of sterility and readiness for production.
• Managing transitions between different product campaigns within a multi-product suite, ensuring smooth changeover without contamination risks or operational issues.
• Performing regular environmental monitoring to ensure the production environment maintains the required sterility and cleanliness standards.
• Ensuring adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and all relevant regulatory guidelines.
• Reviewing and contributing to technical documentation, including manufacturing protocols, batch records, and reports. Ensuring proper documentation of all activities to support regulatory and internal audits.
• Actively participating in cross-functional teams, interacting with teams from R&D, Engineering, Quality Assurance, Supply Chain, Operations, and Validation to improve processes and address manufacturing challenges.
• Supporting and adhering to all Environmental, Health, and Safety (EHS) procedures and policies, ensuring a safe working environment for all personnel.

Qualifications and Experience Required:

• 3rd Level Qualification in a relevant discipline (e.g., Life Sciences, Engineering, Pharmaceutical Sciences, etc.)
• Minimum 12-18 months of experience in the pharmaceutical or medical device industry
• Experience working in cleanroom environments is essential
• Strong understanding of GMP regulatory guidelines and quality systems
• Prior knowledge of aseptic practices is desirable
• Familiarity with drug product manufacturing and validation processes is desirable
• Understanding of autoclave sterilization, depyrogenation, and filter integrity testing is desirable
• Knowledge of lyophilization and freeze dryer operations is desirable
• Experience with single-use technologies is desirable

Skills and Attributes:

• Attention to Detail: Given the aseptic nature of the role, precision and thoroughness in all activities are crucial.
• Knowledge of GMP and SOPs: A strong understanding of these regulatory frameworks ensures the highest level of compliance in the manufacturing process.
• Collaboration Skills: You'll need to work closely with multiple departments (R&D, Quality, etc.), so good communication and teamwork are essential.
• Problem-Solving: Ability to troubleshoot during transitions between different product campaigns and help resolve production challenges.
• Adaptability: Managing a multi-product suite and working with vendors on new technologies requires flexibility and the ability to manage change effectively.
• Well-developed technical writing, organizational, and communication skills are essential

At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.

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