Talent.com
This job offer is not available in your country.
Manufacturing Technician - Co. Mayo

Manufacturing Technician - Co. Mayo

Wallace Myers InternationalMayo
18 days ago
Job description

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.

    Create a job alert for this search

    Manufacturing Technician • Mayo