We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding
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.
12 hour 3 Cycle Shift
Key Responsibilities:
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.
Key Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor’s degree. Emphasis on Biology, Chemistry, Electrical Engineering, Mechanical, Engineering or closely related scientific / technical discipline is preferred. Equivalency: In lieu of a Bachelor’s degree, candidates must have a vocation certification in a technical field, and a minimum of 4 years of related experience in a pharmaceutical, GMP, or EU regulated environment.
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)
What we offer
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!
We look forward to receiving your application!
Grifols is an equal opportunity employer.
Benefits package
Contract of Employment: Permanent position
3 Cycle Shift Pattern
Location: EMEA : Ireland : Dublin:Grange Castle (Dublin)
Learn more about Grifols
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