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Pharmaceutical Engineering Specialist
1 semana atrás
STEPSCIENCE - PHARMA & ENGINEERING is a specialized engineering company catering to the GMP-regulated pharmaceutical and life sciences industries. Our services cover the entire manufacturing lifecycle, from Research and Development to Commercial manufacturing, helping our clients achieve and maintain GMP manufacturing excellence.
We are seeking a skilled CQV Engineer to join our team in Lisbon. As a CQV Engineer, you will be responsible for day-to-day tasks related to commissioning, qualification, and validation of facilities, utilities, equipment and systems, in the pharmaceutical, biotech and life sciences industries, working closely with cross-functional teams and adhering to industry regulations and standards.
This role offers flexibility to work from home, as well as local and international travel requirements.
About the Job
The ideal candidate must have a minimum of 2-years experience in Engineering, Maintenance or CQV within a pharmaceutical, biotech and life sciences environment, and a solid understanding of the Good Manufacturing Practices (GMP).
The candidate must have experience with preparation, execution and closure of CQV documentation such as:
- Preparation of Impact Assessments
- Preparation of Risk Assessments
- Preparation of User Requirements Specification (URS)
- Participation of Enhanced Design Review
- Preparation and execution of Design Qualification (DQ) protocols
- Preparation and execution of Commissioning protocols
- Preparation and execution of Installation Qualification (IQ) protocols
- Preparation and execution of Operational Qualification (OQ) protocols
- Preparation and execution of Performance Qualification (PQ) protocols
Key Responsibilities
- Preparation and execution of CQV documentation
- Participation in cross-functional teams for project management
- Collaboration with engineering, maintenance, and quality assurance teams
- Adherence to industry regulations and standards
- Strong analytical and problem-solving skills
Requirements
- Bachelor's degree or higher in engineering or a related field
- Experience in commissioning, qualification, and validation in the pharmaceutical or life sciences industries
- Knowledge of industry regulations and standards (e.g. FDA, PIC/S, EMA, GAMP 5, ISPE)
- Project Management, strong analytical and problem-solving skills
- Excellent written and verbal communication skills
- Ability to work effectively in cross-functional teams
- Attention to detail and strong organizational skills
- Experience with facilities, utilities, systems, and equipment qualification
- Experience with computerized systems validation
- Passion for on-field work
- Available for working abroad in International projects for periods of time (minimum 1 month)
Benefits
We offer a dynamic work environment, opportunities for professional growth, and a competitive compensation package.
