Operations Specialist II (API Manufacturing)

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

**Job Description Summary**The Operations Specialist will be directly involved in the manufacture of our products to the highest standards of safety, potency, efficacy and quality. The role will work within the guidelines of cGMP to ensure conformance with all regulatory requirements and site SOPs, while assisting in the implementation of process improvements and enhancements.**Job Description**The Shift Operations Specialist will be directly involved in the manufacture of our products to the highest standards of safety, potency, efficacy and quality. The role will work within the guidelines of cGMP to ensure conformance with all regulatory requirements and site SOPs, while assisting in the implementation of process improvements and enhancements. Essential Functions* 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 systemsMinimum Requirements**Education / Experience / Skills:*** 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. The individual in this position will be able to organize their own work on a routine basis and requires minimal supervision.* 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. Incumbents may be asked to perform other duties as required.* 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. Organizational Relationship/Scope:The Operations Specialist is a key frontline role reporting directly to the Operations Lead at College Park Mallinckrodt Pharmaceuticals Manufacturing facility. Working Conditions:**This will be a shift-based role with a shift allowance as part of the renumeration package. Due to the nature of this frontline position, on site work is a requirement.** **Base range -** 39,500 euros to 59,500 euros*At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.**We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.**We are Keenova—keen to solve, keen to serve. Learn more at**www.keenova.com**.*