Experienced Project Manager & Project Engineer for pharmaceutical and medical production & packaging lines, including: Preparation of User Requirement Specifications, Planning and designing of a new plant, Supplier Management, Qualification & Validation o Risk Analysis, CAPA Management
We have collaborated with this consultant before and received only excellent feedback
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Electrical Engineering, Diploma
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Project Engineer, User Requirement Specifications, Basic & Detail Engineering, Qualification, Validation, CSV, CAPEX-Projects, GMP, Pharma / Medical Devices
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany (via K-Recruiting)
Project Engineer URS
Development of concepts and specifications (URS) for optimisation measures for existing filling lines
Ensurance of ompliance with current GMP regulations and regulatory requirements
Pharmaceutical Company, Germany
Project Engineer Qualification & URS
Commissioning, qualification, and validation of automated production equipment
Creating URS (e.g. packaging lines)
Engineering planning and operations support
Measurement, control, and energy supply concepts
Participation in system design, security talks, and process control classification
Deviation, CAPA, Test & Risk Analysis
Specification requirements for EMR and PLS
Cost estimates
Design of actuators and measuring devices
On-site technical task clarification
Explosion protection and safety compliance
Sizing cables, power supplies, switching devices
Procurement of equipment including order processing
Creation of automation function plans, installation, and test documentation
Assembly support and validation of as-built entries
System documentation compilation, maintenance, and archiving
Preparation for recurring tests and GxP compliance
Pharmaceutical Company, Switzerland
Qualification Expert
Commissioning, qualification, and validation of activities for automated production equipment
Creating URS
Deviation, CAPA, Test & Risk Analysis
Preparing the test protocols in the documentation
Coordinating and executing FAT/SAT with suppliers
Preparation of visits to the customer
Compliance with relevant standards (GxP)
Pharmaceutical Company, Switzerland
Qualification/Validation Expert
Commissioning, qualification, and validation of automated production equipment
Writing and executing a Validation Master Plan
Coordinating qualification/validation phases with suppliers
Monitoring development steps per schedule
Preparing the GMP risk analysis
Executing of validation runs
Preparing maintenance / service plans
Check the risk analysis according to FMEA
Ensuring GxP compliance
Pharmaceutical Company, Switzerland
Validation Expert
Commissioning, qualification, and validation of activities for automated production equipment
Incorporation of test methods in validation doc.
Validation of Excel sheets & Execution of test cases
Compliance with relevant standards (GxP)
Medical Devices & Pharmaceutical Company, Switzerland
CQV Engineer
Qualification and validation of automated production equipment
Serialization of production lines
Executing engineering tests and validation runs
Preparing maintenance/service plans
Checking risk analyses per FMEA
Monitoring and verifying process flows
Ensuring GxP compliance