API Manufacturing Ops Specialist II — Shift Premium (cGMP)

Keenova; Dublin; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Shift allowance

Job summary

Keenova is seeking an Operations Specialist II to lead manufacturing processes for API products at our Dublin site. You will ensure safety, quality, and compliance while supporting process improvements and documentation in a cGMP environment.

The role requires collaboration with cross-functional teams, participation in project phases from equipment installation to validation, and training of colleagues on SOPs and procedures. On-site, shift-based position with a base range outlined.

Qualifications

• Minimum certificate level qualification in a related discipline plus 2–3 years relevant experience in a cGMP commercial manufacturing environment.

Responsibilities

• Execute tasks for preparation and production in a cGMP environment with careful attention to detail and documentation.
• Maintain a safe, cGxP compliant work environment at all times.
• Complete tasks per SOPs and Production batch records (PBRs).
• Participate on project teams through start-up phases including equipment installation, commissioning, validation, and qualification.
• Support introduction of new products into sustaining operations through Product Demonstration and Validation activities.
• Assist with troubleshooting for start-up and routine operations in collaboration with Engineering, calibration, and utility maintenance.
• Draft and update area SOPs and batch records.
• Assist with training of colleagues in SOPs and process execution.
• Provide support to Quality Operations when required.
• Drive continuous improvement in process efficiency and compliance.

Skills

Production operations

Attention to detail

cGMP

Documentation

Teamwork

Regulatory compliance

Education

Related discipline certificate/degree

Tools

GMP utilities

Job description

Keenova is seeking an Operations Specialist II to lead manufacturing processes for API products at our Dublin site. You will ensure safety, quality, and compliance while supporting process improvements and documentation in a cGMP environment.

The role requires collaboration with cross-functional teams, participation in project phases from equipment installation to validation, and training of colleagues on SOPs and procedures. On-site, shift-based position with a base range outlined.