Job Description:
We are seeking a highly skilled and detail-oriented individual to join our team as a Pharmaceutical Production Operator.
Key Responsibilities:
* Manufacturing of Pharmaceutical Products:
Oversee the production of materials at various stages of the product lifecycle, including clinical, non-clinical, and pre-clinical stages.
Handle 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, such as sterile, Grade A, or other.
Carry 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.
* Mult-Product Suite Management:
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.
Requirements:
* Skills and Attributes:
o Attention to Detail:
Given the aseptic nature of the role, precision and thoroughness in all activities are crucial.
o Knowledge of GMP and SOPs:
A strong understanding of these regulatory frameworks ensures the highest level of compliance in the manufacturing process.
o Collaboration Skills:
You'll need to work closely with multiple departments (R&D, Quality, etc.), so good communication and teamwork are essential.
o Problem-Solving:
Ability to troubleshoot during transitions between different product campaigns and help resolve production challenges.
o 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:
o Education:
3rd Level Qualification in a relevant discipline (e.g., Life Sciences, Engineering, Pharmaceutical Sciences, etc.).
o 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.
Language: English