Operations Specialist II

Operations Specialist II page is loaded## Operations Specialist IIremote type:
Onsite locations:
College Park, Dublin - IRL
006time type:
Full time posted on:
Posted Yesterday job requisition :
JR
** Job Title
** Operations Specialist II
** Requisition
* * JR Operations Specialist II (Open)
** Location
* * College Park, Dublin - IRL
006
** Additional Locations
**** Job Description Summary
** Job Description  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
** Job Description 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.

The Operations Specialist will assist in facility and equipment modifications, product demonstration and Validation activities as the need arises. The successful candidate will be required to provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.

The Operations Specialist will support safety and quality events, CAPAs and change controls.

The successful candidate will be a person with a strong work ethic, a self-motivated team player with an excellent can-do attitude.  The role will have a strong sense of responsibility, a high emphasis on Quality, Integrity, Discipline and Teamwork.

The role reports to the assigned Manufacturing Operations Shift Lead within the Manufacturing Dept.

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 (P ’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…