Manufacturing Operations Specialist – API GMP

Keenova Therapeutics plc; Dublin; Hybrid; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Shift allowance

Job summary

Keenova Therapeutics plc in Ireland is seeking a Shift Operations Specialist to join our cGMP manufacturing team. You will execute tasks for preparation and production with meticulous documentation and contribute to safety and quality.

The role supports equipment start-up, validation, product introductions, and continuous improvement. It requires 2–3 years in a cGMP environment, ability to work in a team, and strong regulatory compliance. On-site shift with a base salary in the stated range.

Qualifications

• Working knowledge of production operations with a strong focus on attention to detail and compliance to all regulatory standards.
• An ability to work independently and as part of a team.
• Minimum certificate level qualification in a related discipline (Chemistry, Engineering, Biotechnology etc.) plus 2-3 years relevant experience in a cGMP commercial manufacturing environment.
• Knowledge of GMP utility systems (i.e., WFI, clean steam, pharmaceutical gas systems) is desirable
• Experience in working in cross functional teams.
• This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent.
• Good interpersonal and communication skills, verbal and written.
• Collaborator with strong levels of engagement with individuals and teams.
• High level of delivery and work completion.
• A proven track record of delivering on commitments.
• A knowledge of Continuous improvement principles and tools.

Responsibilities

• Responsible for execution of all tasks associated with the preparation for and production of Mallinckrodt products in a cGMP environment ensuring full attention to detail and excellent documentation skills.
• Assist in maintaining a safe, cGxP compliant work environment at all times.
• Responsible for completion of tasks according to SOPs and Production batch records (PBR’s)
• Participate on project teams through all phases of the start-up projects; these phases will include Equipment installation and start up, commissioning, validation, and qualification of equipment.
• Support introduction of new products into sustaining operations through the execution of Product Demonstration and Validation activities
• Support Engineering, calibration, and utility equipment maintenance activities - Perform initial troubleshooting of issues identified during start-up and routine operations.
• Drafting and updating of area SOPs, and batch records.
• Assist with the training of colleagues in SOPs, process execution and equipment operation.
• Provide support to Quality Operations where required.
• Drive a culture of Engagement and Continuous Improvement through identifying and implementing opportunities for improvement in process efficiency and compliance.
• Provide support for initiation and completion of deviations, CAPAs, and change controls for process systems

Skills

Production operations

Attention to detail

Regulatory compliance (cGMP)

Team collaboration

Documentation quality

Education

Certificate in Chemistry or Engineering or Biotechnology

Job description

Keenova Therapeutics plc in Ireland is seeking a Shift Operations Specialist to join our cGMP manufacturing team. You will execute tasks for preparation and production with meticulous documentation and contribute to safety and quality.

The role supports equipment start-up, validation, product introductions, and continuous improvement. It requires 2–3 years in a cGMP environment, ability to work in a team, and strong regulatory compliance. On-site shift with a base salary in the stated range.