About the company 

Memel Biotech AB is early stage supportive ATMP contract development and manufacturing organization providing end-to-end services in every phase of the product development from pre-clinical to manufacturing through to commercialization. The team of skilled, tenacious professionals is expanding and looking for an experienced Validation Engineer to join the Manufacturing department. 

About the role 

As a Validation Engineer, you will be creating and developing procedures and processes to maintain the validated status of our manufacturing unit. The role is a full-time position in Klaipeda, and you would be reporting directly to the Head of Manufacturing. You will be working across multiple functions daily, giving you the unique opportunity to be a part of a growing company, collaborating with highly qualified coworkers. The ideal candidate is motivated and ambitious, sharing our mission to bridge the gap between advanced therapy research and patient treatment.

Responsibilities (amongst others) 

• Oversee, initiate the validation projects and provide expertise. 
• Develop and implement the validation lifecycle procedures of the company, ensure compliance with regulatory requirements and company standards.
• Analyse related data and documentation to assess the performance of manufacturing processes and identify opportunities for improvement.
• Perform qualification and validation studies to demonstrate the reliability of manufacturing processes.
• Implement service, calibration and preventive maintenance program and requalification procedures.
•  Collaborate with cross-functional teams to ensure alignment and coordination of validation activities with project timelines and objectives.
• Investigate and resolve deviations and discrepancies identified during validation activities.
• Comply with the company policies and quality management system.

Skills and Qualifications:

• Bachelor’s degree in a relevant area such as pharmaceuticals, biotechnology or life sciences or equivalent degree from an accredited university/ college.
• Minimum 3-5 years of experience as a Validation Engineer, preferably in the biopharmaceutical industry. 
• Knowledge in application of GMP and regulatory requirements 
• Proven experience in validation of pharmaceutical facilities and equipment, automated systems. 
• Ability to multi-task, strong analytical and organizational skills, detail oriented.
• Ability to communicate clearly and effectively with all levels of the organization and regulatory authorities.
• Strong written and communication skills in Lithuanian (mandatory) and English (mandatory). 

Personal attributes

You are driven, independent and proactive in taking on initiatives. You strive to maintain good relationships internally and externally and have a supportive and collaborative working attitude. You handle challenging, high-pressure situations with ease and composure. Your positive and helpful personality will be of highest importance for this position. 

Equal Opportunity Work

At Memel Biotech, we are committed to fostering a diverse and inclusive workplace where all employees, regardless notably of gender, race, religion, or age, have equal opportunities for personal and professional growth. Equality is not only a matter of social justice but also a vital component of a thriving and innovative organization. We strive to foster professional yet personal collaboration. 

We offer:

• Professional career development/growth opportunities.
• Flexible working hours.
• Options for remote work when there is a need. 
• Professional development opportunities (training programs, conferences etc.).
• Full-time position with valuable work experience and excellent working conditions.
• Regular team building activities.
• Relocation package.
• Gross salary starting from 3500 Eur./month (depends on experience and competences).

Please send us your CV to info@memelbiotech.com.