CQV Engineer
Vor 2 Tagen
We are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will be responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.
Key Responsibilities:- Perform activities related to commissioning, qualification, requalification, and validation independently.
- Commission, qualify, and requalify new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines such as GMPs or FDA.
- Qualify computerized and automation systems.
- Write qualification documents such as VP, IQ, OQ, PQ, and PPQ protocols and reports, risk assessments, and development protocols.
- Support the development of user requirements and functional specifications.
- Participate in all phases of validation projects in accordance with client needs.
- Recommend to management the acceptance and release of qualified equipment, facilities, services, and systems.
- Support the generation and execution of documentation related to demonstration batches, thermal studies, validation studies for equipment, engineering test runs, and development studies.
- Review technical and quality system documents such as SOPs, Change Control, Deviation Reports, and Batch Production Records, ensuring any document changes meet quality and validation requirements and are in full compliance with regulations, standards, and regulatory compliance issues.
- Provide technical assistance during investigations of process/equipment/cleaning/validation issues and aid in the resolution of validation deviations, protocol discrepancies, and non-conformities.
- Provide effective solutions for the management of system deviations and non-conformities through the CAPA System.
- Bachelor's degree in a technical field (engineering, biology, chemistry, pharmacy).
- At least 3 years of experience in QA Oversight for C&Q activities, in Biopharma or Pharma industry.
- Generation and overview of qualification documents like URS, System Risk Assessment, DQ, IQ, OQ, PQ, SOPs.
- Hands-on commissioning, qualification, and validation experience in facilities, utilities, major qualification equipment, process and cleaning validation, equipment qualification, computer software validation.
- Firm understanding of cGMP validation requirements/guidelines and familiarity with FDA regulatory requirements for the Pharmaceutical/Biopharmaceutical industry.
- Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.
- Experience with Microsoft Office Suite.
- Fluency in English and German is a must.
- EU citizenship mandatory.
- Full-Time Position
- Competitive Salary
- Opportunities working for a global company.
- Private Healthcare
- Thirty (30) days Holiday
- Continuous Professional Improvement including, but not limited to, courses or seminars.
We are an equal opportunity workplace and welcome applications from diverse candidates. Please send your CV in English for consideration.
-
CQV Engineer
Vor 3 Tagen
Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology VollzeitJob Title: CQV EngineerWe are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will be responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.Key...
-
CQV Engineer
Vor 3 Tagen
Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology VollzeitJob Title: CQV EngineerWe are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will be responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.Key...
-
CQV Engineer
Vor 2 Tagen
Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology VollzeitJob Title: CQV EngineerWe are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will be responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.Key...
-
CQV Engineer
Vor 2 Tagen
Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology VollzeitJob Title: CQV EngineerWe are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will be responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.Key...
-
CQV Engineer
vor 1 Woche
Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology VollzeitAbout the RoleWe are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' pharmaceutical and biopharmaceutical products.Key ResponsibilitiesCommissioning, qualification, and requalification of new or existing manufacturing and...
-
CQV Engineer
vor 1 Woche
Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology VollzeitAbout the RoleWe are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' pharmaceutical and biopharmaceutical products.Key ResponsibilitiesCommissioning, qualification, and requalification of new or existing manufacturing and...
-
CQV Engineer
vor 2 Wochen
Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology VollzeitAbout the RoleWe are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' pharmaceutical and healthcare products.Key ResponsibilitiesProvide direct services to site Technical Services management, aiding to increase the throughput...
-
CQV Engineer
vor 2 Wochen
Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology VollzeitAbout the RoleWe are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' pharmaceutical and healthcare products.Key ResponsibilitiesProvide direct services to site Technical Services management, aiding to increase the throughput...
-
CQV Engineer
vor 2 Wochen
Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology VollzeitAbout the RoleWe are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' pharmaceutical manufacturing processes.Key ResponsibilitiesCommissioning, qualification, and requalification of new or existing manufacturing and laboratory...
-
CQV Engineer
vor 2 Wochen
Leverkusen, Nordrhein-Westfalen, Deutschland PharmEng Technology VollzeitAbout the RoleWe are seeking a highly skilled CQV Engineer to join our team at PharmEng Technology. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our clients' pharmaceutical manufacturing processes.Key ResponsibilitiesCommissioning, qualification, and requalification of new or existing manufacturing and laboratory...
-
Senior Validation Engineer
vor 2 Wochen
Leverkusen, Nordrhein-Westfalen, Deutschland Exyte VollzeitJob SummaryExyte is seeking a highly skilled Senior Validation Engineer to join our team in the Bio Life Sciences sector. As a Senior Validation Engineer, you will be responsible for handling project-specific qualification and validation activities according to current GMP regulations.Key ResponsibilitiesResponsible handling of project-specific qualification...
-
Senior Validation Engineer
vor 2 Wochen
Leverkusen, Nordrhein-Westfalen, Deutschland Exyte VollzeitJob SummaryExyte is seeking a highly skilled Senior Validation Engineer to join our team in the Bio Life Sciences sector. As a Senior Validation Engineer, you will be responsible for handling project-specific qualification and validation activities according to current GMP regulations.Key ResponsibilitiesResponsible handling of project-specific qualification...
-
CQV Engineer
vor 4 Monaten
Leverkusen, Deutschland PharmEng Technology VollzeitPharmEng Technology is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years. Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical...
-
CQV Engineer
vor 4 Monaten
Leverkusen, Deutschland PharmEng Technology VollzeitPharmEng Technology is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years. Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical...
-
CQV Engineer
vor 2 Monaten
Leverkusen, Deutschland PharmEng Technology VollzeitPharmEng Technology is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years.Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical...
-
Engineer Qualification
vor 1 Monat
Leverkusen, Deutschland Exyte VollzeitYour vision is ambitious . Just like ours. Our people are our success. As one of us, you will contribute to engineering excellence for the high-tech markets of the future, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. At Exyte, you will be part of a global community of challenge seekers who are ambitious and...
