Back to Jobs search

Operations Specialist II (API Manufacturing)

Mallinckrodt Pharmaceuticals • United States, United States • 1w ago

Job Title

Requisition

JR000015865 Operations Specialist II (API Manufacturing) (Open)

Location

College Park, Dublin - IRL006

Additional Locations

Job Description Summary

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 systems

Minimum 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 .

At Keenova, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.

Invest in your own career with Keenova and let's do something dynamic together.

Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.

Additional information on Keenova's hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)

Similar Jobs

Electric Motor Mechanic (All Levels) - Senior Preferred

Energy Management Corporation • Salt Lake City, UT • 2h ago

Manufacturing & Warehouse

Electric Motor Mechanic (All Levels) - Senior Preferred Both Day and Swing Shifts Available Location: Salt Lake City, UT Energy Management Corporation (EMC) If you take pride in fixing what others can't-and enjoy working...

2h ago

Go to Apply

Field Inspector Distribution (Electric)

TECO Energy • Tampa, FL • 2h ago

Manufacturing & Warehouse

Power up a career with us. Our people are our greatest investments. Be the light to help us keep our customers connected. If you are interested in a career and not just a position, Tampa Electric is the place to be! Tamp...

2h ago

Go to Apply

Demand Planner - Manufacturing

Wescon Controls • Wichita, KS • 5h ago

Manufacturing & Warehouse

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13626400 [Job Summary:]{.underline} The Demand Planner is responsible for planning and controlling a...

5h ago

Go to Apply

Head of Contract Manufacturing

Siemens • Wendell, NC • 5h ago

Manufacturing & Warehouse

Job Family: Electrification & Automation Req ID: 516415 Head of Contract Manufacturing SI EA US Here at Siemens, we take pride in enabling sustainable progress through technology. We do this by empowering customers t...

5h ago

Go to Apply

Head of Contract Manufacturing

Siemens • Kenosha, WI • 5h ago

Manufacturing & Warehouse

5h ago

Go to Apply

Manufacturing Supervisor- Cheese

Kroger Family of Companies • Rochester, MN • 5h ago

Manufacturing & Warehouse

Plan, coordinate and supervise daily activities of assigned department; ensure efficient operations. Perform all jobs safely, efficiently and accurately to maintain and improve the performance of the entire plant in the...

5h ago

Go to Apply

Manufacturing Operator III

Materion Corporation • Buffalo, NY • 5h ago

Manufacturing & Warehouse

The Bonding Tech sets up and operates manufacturing equipment associated with material fabrication and target bonding.You will get the opportunity to: Operate various equipment including, but not limited to saws, grinder...

5h ago

Go to Apply

Manufacturing Coordinator

Kerry • Chicago, IL • 5h ago

Manufacturing & Warehouse

?Requisition ID 66055 Position Type (US)Full Time Workplace Arrangement About Kerry Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with...

5h ago

Go to Apply

Manufacturing Associate (Pharmaceuticals)

Astrix Technology • Covington, GA • 5h ago

Manufacturing & Warehouse

Manufacturing Associate (Pharmaceuticals) Manufacturing Covington, Georgia, US Added - 31/07/2026 Pay Rate Low: 26.00 | Pay Rate High: 28.00 Join our pharmaceutical manufacturing team as a Manufacturing Associate and pla...

5h ago

Go to Apply

Manufacturing Domain Leader

DuPont • Wilmington, DE • 5h ago

Manufacturing & Warehouse

At DuPont, our purpose is to empower the world with essential innovations to thrive. We work on things that matter. Whether it's providing clean water to more than a billion people on the planet, producing materials that...

5h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)