3 cycle shifts
€35,000 plus shift allowance
Health Insurance, Pension , Great Place to Work
Within this role you are responsible for the coordination, operation and maintenance of the packaging lines in support of manufacturing requirements, and to ensure the process meets cGMP (current Good Manufacturing Practices) and company standards.
- Set up, coordinate, regulate and troubleshoot packaging assembly line equipment in a biologics processing environment for plasma derived pharmaceuticals.
- Perform visual inspection of product vials in accordance with specifications.
- Manually, or with the help of material handling equipment, load, unload, palletize, and distribute materials and products.
- Adhere to procedures and practices and maintain compliance with applicable departmental, corporate, industrial standards and/or applicable health, safety and regulatory requirements of a competent regulatory body.
- Responsible for the accuracy and completeness of batch documentation and material reconciliation.
- Responsible for cleaning facilities and equipment and for ensuring packaging machineries are maintained in proper working order. Perform basic calibration, preventive maintenance and repair work.
- Recommend and implement measures to improve production methods, equipment performance, facility layout, and quality of product.
- Maintain a quality presence to ensure compliance with all regulatory requirements.
- Maintain current knowledge of regulatory and industry standards.
- Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
- Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
- Provide guidance and hands-on training to peers and/or direct reports and ensure all training records are up to date and in line with training SOP's.
- Minimum of 1-3 years of related experience in a pharmaceutical, GMP, or EU regulated environment is required.
- 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 interpersonal skills with the ability to interact with personnel at all levels in a team environment.
- 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 others and align team members around shared goals.
- Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel.
- Comprehensive knowledge and understanding of cGMPs, EU regulations, and industry guidelines highly preferred.
- Excellent verbal and written communication skills in the English language.
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, Powerpoint).