Maja Smilevska

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Senior CQV Engineer

Ref #: ID: 32083
Maja Smilevska 21/04/2022
Location: Karlsruhe, Germany, Switzerland Not Disclosed Karlsruhe, Germany, Switzerland
Salary: TBC £
Type: Permanent
Seniority: Mid/Senior Level
Specialisms: CSV (Computer System Validation)
Date: 21/04/2022
Senior CQV Engineer

As Senior CQV Engineer (Commissioning, Qualification & Validation) you are responsible for qualification, verification, and validation of pharmaceutical equipment at the customer’s site. While the offices are located in Karlsruhe, our client support working from remote / from home!

Your role within the team
• You are responsible for CQV activities from planning to specification to acceptance of a machine
• You support our well-known pharmaceutical customers with design and execution of their qualification (and validation) activities in a regulated industry
• You lead and train junior team members
• You are responsible for machine-specific documentation (URS, designs, risk analysis, test plans etc.) and verification strategies following needs of the regulated industry to achieve quality and compliance
• You perform or support project management activities
• You support the customer with the required range of SOPs and provide the required guidance.

Your profile
• You have an engineering degree or equivalent qualification as master / technician (f/m/d)
• You know the requirements, regulations, guidelines, cGMPs, and best practices of the pharmaceutical and biotech industry (FDA, EU, ICH, ASTM E2500, GAMP 5, …)
• You come with multi-year project engineering expertise (pharmaceutical or biotech industry preferred)
• You are a team player with good communication, time management, and problem-solving skills
• You have a demonstrated ability to interact effectively with all levels of an organization
• You are willing to travel regionally and internationally
• Your come with basic understanding of documentation that supports PCS (e.g. P&ID’s, electrical drawings, certificates of conformance, pneumatic drawings, etc.)
• Domain knowledge or experience with packaging and inspection machines, filling machines, lyophilization, super-ordinated systems (e.g., ERP, MES, DCS, historian), and items related to WFI, HVAC, cleanrooms, utilities etc. is a plus • German language skills are a plus

Your benefits
• Unlimited contracts and flexible working arrangements
• An innovative job in a national and international environment
• Exciting challenges and a long-term perspective for personal development in a growing team
• A state-of-the-art working environment in a highly motivated and professional team
• Flat hierarchies and a considerate and friendly working atmosphere
• Very interesting insights into the business world at a variety of our customers
• Many exciting career opportunities for the future
• Attractive and performance-related compensation
• At the Karlsruhe location: in-house childcare, fitness studio, cafeteria

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