Manufacturing Technician

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:
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.
Aseptic Processing and Compliance:
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.
Collaboration on New Technologies:
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:
Preparing components, tools, and equipment for processing into Grade A environments, ensuring the highest levels of sterility and readiness for production.
Multi-Product Suite Management:
Managing transitions between different product campaigns within a multi-product suite, ensuring smooth changeover without contamination risks or operational issues.
Environmental Monitoring:
Performing regular environmental monitoring to ensure the production environment maintains the required sterility and cleanliness standards.
Regulatory Compliance:
Ensuring adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and all relevant regulatory guidelines.
Documentation and Reporting:
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:
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:
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 desirableTechnical 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 desirableSkills:

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
If interested in this posting, please feel free to contact Jack Caffrey at () or for further information.

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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