We're currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Mayo. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
This is a 12-hour shift role.
Key Responsibilities:
* Manufacturing of Pharmaceutical Products:
o Overseeing the production of materials at various stages of the product lifecycle (clinical, non-clinical, and pre-clinical stages).
o Handling batch preparation activities such as vial washing, load sterilization, and area preparation for production.
* Aseptic Processing and Compliance:
o Performing activities in accordance with the required cleanliness classification of the production area (e.g., sterile, Grade A, or other).
o Carrying out sterile operations such as compounding, sterile filtration, and sterile filling.
* Collaboration on New Technologies:
o Working with external vendors to help develop or improve systems related to single-use technologies, ensuring their effective integration into the manufacturing process.
* Preparation and Setup for Processing:
o 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.
* Regulatory Compliance:
o Ensuring adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and all relevant regulatory guidelines.
* Documentation and Reporting:
o 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.
* Cross-Functional Team Collaboration:
o 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.
* EHS (Environmental, Health, and Safety) Compliance:
o Supporting and adhering to all Environmental, Health, and Safety (EHS) procedures and policies, ensuring a safe working environment for all personnel.
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.
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.
Qualifications and Experience Required:
Educational Background:
* 3rd Level Qualification in a relevant discipline (e.g., Life Sciences, Engineering, Pharmaceutical Sciences, etc.)
Professional Experience:
* Minimum 12-18 months of experience in the pharmaceutical or medical device industry
* Experience working in cleanroom environments is essential
* Prior knowledge of aseptic practices is desirable
Technical Expertise and Knowledge:
* Strong understanding of GMP regulatory guidelines and quality systems
* 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:
* Well-developed technical writing, organizational, and communication skills are essential
* Experience working in project and team-based environments is essential
* A pro-active approach with strong problem-solving skills is desirable
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