Process Validation Specialist (208746BR)
Process Validation Specialist (208746BR)
Process Validation Specialist (208746BR)
Process Validation Specialist (208746BR)
Process Validation Specialist (208746BR)

Process Validation Specialist (208746BR)THERMO FISHER SCIENTIFIC

Job description:

Position purpose: This role is responsible for leading process validation activities in Vilnius Operations. Together with manufacturing and quality assurance teams this specialist will create new or update existing process validation plans, forms, and reports, will coordinate activities during validations.

Key Responsibilities:
• Leads process validation activities:
• Ensures all vital quality standards are met and processes are validated.
• Initiates and actively leads meetings for process validation strategy development.
• Coordinates different activities during process validation.
• Timely fulfils planned activities and provides plans, forms and rapports.
• Suggests manufacturing process improvement to better meet ISO standard requirements.
• Ensures an effective manufacturing teams support during process validation.
• Actively indicates risks and translates them to the validation team.
• Manages validation documentation:
• Creates, updates, and approves validation plans, forms, and rapports.
• Generates ideas how to standardize and improve documents creation process.
• Manages non-conformities and deviations during process validation:
• Analyzes batch records, testing and development data to identify variations.
• Generates ideas how to find the root cause.
• Actively uses PPI tools and methods:
• Participates and manages JDI and Kaizens
• Goes to GEMBA walks and implements 5 S
• Is an active team member:
• Generates ideas and executes process improvement.
• Provides technical expertise and knowledge on validation to manufacturing group and beyond.
• Willingly shares technical knowledge with others.


• University Bachelor’s or Master’s degree in molecular biology, chemistry, biochemistry, genomics, or similar fields.
• Excellent English language skills.
• Computer literacy (MS Office 365).
• Knowledge of biotechnology processes.
• Knowledge of analytical methods used in biotechnology.
• Knowledge of general principles of documentation.
• Activity, responsiveness, self-confidence.
• Creativity, ingenuity, perseverance in solving problems and finding solutions.
• Communicability, ability to communicate effectively with employees of different levels.
• Organization, ability to anticipate priorities, focus on customer needs and expectations.
• Enthusiasm, strong desire to constantly improve their own and the unit's activities.
• Willingness to put in extra effort (and time) to complete tasks on time.
• Willingness to share professional experience and knowledge with other employees.
• Willingness and ability to recognise and escalate about threats to the environment, product quality, daily tasks, and / or the Company and the desire to engage in reducing and improving processes.

The Company offers:

• Meaningful, mission-based work.
• The innovative environment of the rapidly growing international company.
• High performing, driven and supportive working culture and outstanding development possibilities to increase your potential.
• An exciting opportunity to be part of a dynamic global organization and work with experienced professionals.
• Professional career opportunities.
• Work in an ambitious team.
• Monthly salary 1500 - 2300 Eur (Brutto) and additional benefits package.

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