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- Aufgaben: Join our team to ensure top-notch pharmaceutical equipment is qualified and validated.
- Arbeitgeber: Be part of a leading pharmaceutical manufacturing company dedicated to quality and compliance.
- Mitarbeitervorteile: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Warum dieser Job: Make a real impact in healthcare by ensuring the safety and efficacy of pharmaceutical products.
- Gewünschte Qualifikationen: Bachelor’s degree in Engineering or Life Sciences; experience in equipment qualification is a must.
- Andere Informationen: Work closely with diverse teams and tackle exciting challenges in a regulated industry.
Das voraussichtliche Gehalt liegt zwischen 42000 - 84000 € pro Jahr.
We are seeking a highly motivated Performance Qualification (PQ) Engineer to join our pharmaceutical manufacturing team. The successful candidate will be responsible for the qualification and validation of critical equipment such as parts washers, autoclaves, and thermal mapping systems. This role ensures compliance with industry regulations and supports the delivery of high-quality pharmaceutical products. Key Responsibilities: Perform Performance Qualification (PQ) activities for pharmaceutical manufacturing equipment, including parts washers, autoclaves, and thermal mapping systems. Develop, execute, and review qualification protocols (IQ, OQ, PQ) in accordance with cGMP and regulatory standards. Analyze and interpret validation data, ensuring compliance with industry best practices. Support thermal mapping studies for controlled storage environments, ensuring temperature and humidity consistency. Collaborate with cross-functional teams including Quality Assurance, Engineering, and Manufacturing to optimize equipment performance. Maintain detailed documentation and reports for audits and regulatory inspections. Troubleshoot and resolve validation issues as they arise. Requirements: Bachelor’s degree in Engineering, Life Sciences, or a related field. Previous experience in equipment qualification and validation within a pharmaceutical or regulated manufacturing environment. Strong understanding of cGMP, FDA, and EU regulatory requirements. Hands-on experience with parts washers, autoclaves, and thermal mapping. Excellent analytical, problem-solving, and documentation skills. Strong communication and teamwork abilities. #J-18808-Ljbffr
Performance Qualification (PQ) Engineer Arbeitgeber: Whatjobs
Kontaktperson:
Whatjobs HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Performance Qualification (PQ) Engineer
✨Tip Number 1
Familiarize yourself with cGMP and regulatory standards relevant to the pharmaceutical industry. Understanding these guidelines will not only help you in your role but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical manufacturing field. Attend industry conferences or join relevant online forums to connect with others who can provide insights and potentially refer you to job openings.
✨Tip Number 3
Gain hands-on experience with the specific equipment mentioned in the job description, such as parts washers and autoclaves. If possible, seek internships or volunteer opportunities that allow you to work directly with this equipment.
✨Tip Number 4
Prepare for technical interviews by reviewing common PQ scenarios and validation challenges. Being able to discuss real-world examples of how you've handled similar situations will set you apart from other candidates.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Performance Qualification (PQ) Engineer
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Performance Qualification (PQ) Engineer position. Understand the key responsibilities and requirements, especially the importance of cGMP and regulatory standards in the pharmaceutical industry.
Tailor Your CV: Customize your CV to highlight relevant experience in equipment qualification and validation. Emphasize your hands-on experience with parts washers, autoclaves, and thermal mapping systems, as well as your understanding of regulatory requirements.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your motivation for applying and how your skills align with the role. Mention specific experiences that demonstrate your analytical and problem-solving abilities in a regulated manufacturing environment.
Prepare for Potential Questions: Anticipate questions related to your experience with PQ activities and regulatory compliance. Be ready to discuss specific examples of how you've contributed to equipment performance optimization and handled validation issues in the past.
Wie du dich auf ein Vorstellungsgespräch bei Whatjobs vorbereitest
✨Show Your Technical Knowledge
Be prepared to discuss your experience with equipment qualification and validation. Highlight specific examples of how you've worked with parts washers, autoclaves, or thermal mapping systems in previous roles.
✨Understand cGMP and Regulatory Standards
Familiarize yourself with current Good Manufacturing Practices (cGMP) and relevant FDA and EU regulations. Be ready to explain how you ensure compliance in your work and how it impacts product quality.
✨Demonstrate Problem-Solving Skills
Prepare to discuss challenges you've faced in validation processes and how you resolved them. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Emphasize Team Collaboration
Since this role involves working with cross-functional teams, be sure to share examples of successful collaborations. Highlight your communication skills and how you contribute to team success.
