Quality Assurance Senior Engineer

Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a strong international presence, we remain committed to improving people’s lives through innovation and access to affordable, high-quality medicines. Today, our products reach patients in more than 90 countries worldwide, supporting better health outcomes every day.

Pharmathen employs more than 1,600 people from over 27 different nationalities, reflecting a diverse and international workforce. Our achievements are driven by strong scientific expertise, high ethical standards, and the dedication of our people, who share a commitment to improving patient lives.

Pharmathen offers a great opportunity for career development and is seeking to recruit a Quality Assurance Senior Engineer to join our Quality Assurance team at our Pallini premises.

As a Quality Assurance Senior Engineer, the ideal candidate will ensure compliance of equipment, processes and plant areas to EU cGMPs and ISO requirements, be responsible for organizing new areas and equipment projects as per quality demands and for customer communication regarding engineering topics and interdepartmental communication, and play a key role in all calibration/qualification activities.

More particularly:

What you’ll do:

• Responsible for issuance of TDR and SOPs relevant to operation, maintenance, cleaning and validation/qualification activities of areas and equipment
• Ensure compliance with legislation requirements regarding change controls, deviations, risk management related to equipment and areas
• Ensure compliance to the Quality Management System according to ISO 9001:2015 and EU cGMPs
• Responsible for the preparation and control of the controlled layouts of the plant and the warehouses
• Responsible for issuance, conducting and monitoring of protocols, that will be used for validation and/or qualification of equipment, warehouse and production areas
• Keep a key role in project plans regarding new areas and equipment and have the main role for internal and subcontractors communication
• Design, develop, execute, monitor and control the internal Validation/Qualification procedures of the equipment/premises, utilities and production areas and evaluate findings of measurements and studies, according to legislation and company’s standards
• Design, develop, execute, monitor and control the Validation/Qualification procedures provided by external parties, for the equipment/premises, utilities and production areas and evaluate findings of measurements and studies, according to legislation and company’s standards
• Responsible for the training of production, warehouse and technical personnel related to the controls – measurements in regards to validation & qualification of equipment and plant areas
• Monitor the environmental conditions of production, quality control and warehouse areas, as well as, utilities
• Monitor of maintenance activities of the facility and the external warehouses
• Keep a key role in all calibration/ qualification activities of the site and the external warehouses
• Maintain basic role in troubleshooting regarding technical issues of the site and the external warehouses

Requirements:

• BSc in Engineering or relevant field
• 3-5 years’ experience in calibration/ qualification sectors

Job-Specific Skills:

• Excellent communication in English language (writing & speaking)
• Computer literacy
• Ability to prioritize tasks and meet deadlines
• Problem Solving Skills
• Deep knowledge of global legislation requirements
• Strong initiative and creativity skills
• Strong teamwork and collaboration skills

What you'll gain:

• Involvement in a high-caliber, team-oriented and dynamic atmosphere
• Exposure to challenging business issues and practices
• Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.

Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin