Job Description
We are currently recruiting for an exciting opportunity with a leading pharmaceutical organization based in Mayo.
Key Responsibilities:
* Manufacturing of Pharmaceutical Products: Oversee 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.
* Aseptic Processing and Compliance: Perform 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.
* Collaboration on New Technologies: Work 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: Prepare components, tools, and equipment for processing into Grade A environments, ensuring the highest levels of sterility and readiness for production.
* Multi-Product Suite Management: Manage transitions between different product campaigns within a multi-product suite, ensuring smooth changeover without contamination risks or operational issues.
* Environmental Monitoring: Perform regular environmental monitoring to ensure the production environment maintains the required sterility and cleanliness standards.
* Regulatory Compliance: Ensure adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and all relevant regulatory guidelines.
* Documentation and Reporting: Review and contribute to technical documentation, including manufacturing protocols, batch records, and reports.
* Ensure proper documentation of all activities to support regulatory and internal audits.
* Cross-Functional Team Collaboration: Actively participate 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: Support and adhere 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