Qualification & Validation - Senior Engineer

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Michael Bailey Associates - Munich
flag_no Schweiz

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We are recruiting for a Freelance Qualification & Validation Engineer (for a short 3 month contract - extendable) for our multinational client, specialising in Biotechnology & Medical Devices in Bern.


- Define & Perform the qualification strategy for laboratory equipment, facilities, utilities and Computerized Systems (CSV) and prepare the necessary documentation according to international GMP standards

- Collaborate in the upgrading of documents and life cycle management of existing laboratory equipment, facilities and utilities according to a predefined frequency and in accordance with current SOPs.

- As Process Owner, follow and adhere to the rules and procedures of the equipment Commissioning & Qualification process.

- Contribute in the implementation of documented investigations for any deviations to the current practices and operating procedures.

- Contribute in the definition and implementation of corrective and preventive actions related to equipment Commissioning and Qualification process.

- Ensure that work activities within own area of competence is carried out in accordance with current legislation in the field of Safety, Environment and Hygiene standards.

- Constantly contribute to cost containment and improvement of standards identifying, proposing and implementing process improvements, rationalization and standardization of products and packaging materials in line with corporate policies and objectives established. 


- Writing and review of commissioning and qualification documents for equipment, utilities, facilities, and computerized systems.

- Definition of risk-based Commissioning and Qualification strategies.

- Deviation and CAPA management.

- Change Control Management.


- Engineer or experienced Bachelor with experience in the pharmaceutical/medical device of at least 3-5 years

- Knowledge of current GMP standards and guidelines related to equipment, utilities and facilities qualification (eg ISO, ICH, FDA, ISPE)

- Knowledge of the necessary qualification and validation steps and tools (FMEA/HACCP RA, URS, DQ, IQ, OQ, PQ, SD&V, FPX)

- Knowledge of Good Engineering Practices

- Practical experience in the technical support of sterile production areas, as a plant engineer, internal project manager

- Detailed knowledge of GMP/HACCP requirements and their technical implementation in clean room classes A to D (EUGMP)

- Proactive, open personality that recognizes Production, Quality and R&D Departments as internal customers

- Team player with excellent communication skills

Please send CVs or call

Michael Bailey International is acting as an Employment Business in relation to this vacancy.