Manufacturing Operations Technician

Location
Dublin
Salary
health insurance ,pension, 25 days hols
Posted
23 Nov 2020
Closes
21 Dec 2020
Ref
Manufacturing Ops
Contact
Manpower Dublin
Sector
Manufacturing
Job Type
Permanent
Hours
Full-time

4 cycle (24/7) Manufacturing Operations Technician

Reporting to the Shift Supervisor, the successful candidate is responsible for the operation, cleaning and upkeep of all equipment and facilities in a cleanroom environment in support of manufacturing requirements.
Responsible for the adherence to, and ownership of, all cGMP, training and safety standards for their work area.


Key Responsibilities


*Assist with the creation and maintenance of area SOPs and validation documents for equipment and procedures, and assist in the writing of area status reports, regulatory documents, and process descriptions.
*Ensure safe and timely completion of all process activities according to cGMP's.
*Adhere to procedures and practices and maintain compliance with applicable departmental, corporate, industrial, health & safety and regulatory requirements.
*Ensuring that the gowning philosophies for all cleanroom, production and facility areas are strictly adhered to and all non-conformances are immediately actioned and reported.
*Ownership for the setup, coordination, regulation and troubleshooting of processing equipment in all cleanroom environments
*Responsible for the cleaning (Manual and automated CIP/SIP) and upkeep of all associated facilities and equipment and for ensuring all areas are maintained in proper working order.
*Maintain a safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment.
*Ability to operate automated scada-controlled/windows-based control systems in a GMP environment.
*Recommend and implement measures to improve production methods, equipment performance, facility layout, and quality of product. Actively participate in the company's Continuous Improvement programs.
*Co-operate and support quality investigations and contribute to CAPA reporting and closure.
*Provide guidance and hands-on training to peers and colleagues and ensure all training records are up to date and in line with training SOP's, OJT's and policies.
*Capable of maintaining production without supervision, anticipates and adjusts for interventions, effectively manages multiple priorities
*Performs other duties as assigned by Manufacturing Supervisors to meet the needs of the business
*Making decisions specific to their area of work in a timely manner.


Education/Experience

To be successful in this role you will require:

*Prior relevant experience in a regulated manufacturing operations environment.
*Working knowledge of production operations, scheduling, design, planning, etc.
*Knowledge of lean management systems.
*Previous experience defining and establishing policies and SOPs.
*Excellent communication, and interpersonal skills.
*An ability to work independently and as a member of a team in a dynamic, fast-paced and goal driven environment.
*Must be proactive, results oriented, and have strong attention to detail.
*Self-starter with strong work ethic and the ability to exercise good judgment.
*Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
*Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
*Demonstrated ability to inspire high performance in self and others and support team members around shared goals.
*Comprehensive knowledge and understanding of cGMPs, EU regulations, and industry guidelines highly preferred.
*Must be available to work shift as directed by the organization.
*Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint
*Bachelor's degree preferred: Emphasis on Biology, Chemistry, Manufacturing or Mechanical Engineering or closely related scientific / technical discipline desired. Equivalency: In lieu of a bachelor's degree, candidates must have a minimum of 2 years of related experience in a pharmaceutical, GMP, or EU regulated environment

 

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