PQE Group
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Direct message the job poster from PQE Group
Are you ready to join a world leader in the exciting and dynamic fields of the
Pharmaceutical and Medical Device industries ?
PQE Group
has been at the forefront of these industries since
1998 , with 40 subsidiaries and more than
2000 employees in Europe, Asia and the Americas.
As a Commissioning & Qualification (CQ) Expert in
Bulk Production, Utilities, and Filling , you will be responsible for planning, executing, and documenting all commissioning and qualification activities for pharmaceutical manufacturing systems and equipment. You ensure that new or modified systems operate in compliance with GMP and meet all regulatory requirements.
❗The ideal candidate is comfortable to travel in
DACH-Area , depending on the project phase and on-site activity needs.
Responsibilities
Plan and execute
Commissioning & Qualification activities
for process equipment in Bulk Production, Utilities, and Filling areas.
Prepare and review
CQ documentation
such as URS, risk assessments, DQ, IQ, OQ, and related technical documents.
Support and monitor the
commissioning of equipment, systems, and utility supply
infrastructures.
Collaborate closely with Engineering, Production, QA, Automation, and external vendors.
Identify and assess
quality and compliance risks
and propose adequate mitigation measures.
Ensure adherence to
GMP, GEP, GAMP5, and relevant regulatory guidelines .
Support
deviations, CAPAs, and change controls
in the context of qualification projects.
Coordinate and/or execute
FAT/SAT
activities and support validation tasks.
Contribute to continuous improvement of processes, standards, and CQ strategies.
About you
Degree in
Pharmaceutical Sciences, Chemical/Process Engineering, Biotechnology , or a comparable field.
Several years of experience in
Commissioning & Qualification
within the pharmaceutical industry.
Strong technical knowledge in
process equipment, utilities, cleanrooms, or filling processes .
Solid understanding of
GMP regulations , EU/FDA requirements, and modern science- and risk-based qualification approaches.
Proficient in working with technical documentation and quality systems.
Analytical, structured mindset with excellent communication and teamwork skills.
Very good command of both
English and German
Willing to travel
Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
Seniority level Mid-Senior level
Employment type Full-time
Job function Consulting
Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing
#J-18808-Ljbffr
Direct message the job poster from PQE Group
Are you ready to join a world leader in the exciting and dynamic fields of the
Pharmaceutical and Medical Device industries ?
PQE Group
has been at the forefront of these industries since
1998 , with 40 subsidiaries and more than
2000 employees in Europe, Asia and the Americas.
As a Commissioning & Qualification (CQ) Expert in
Bulk Production, Utilities, and Filling , you will be responsible for planning, executing, and documenting all commissioning and qualification activities for pharmaceutical manufacturing systems and equipment. You ensure that new or modified systems operate in compliance with GMP and meet all regulatory requirements.
❗The ideal candidate is comfortable to travel in
DACH-Area , depending on the project phase and on-site activity needs.
Responsibilities
Plan and execute
Commissioning & Qualification activities
for process equipment in Bulk Production, Utilities, and Filling areas.
Prepare and review
CQ documentation
such as URS, risk assessments, DQ, IQ, OQ, and related technical documents.
Support and monitor the
commissioning of equipment, systems, and utility supply
infrastructures.
Collaborate closely with Engineering, Production, QA, Automation, and external vendors.
Identify and assess
quality and compliance risks
and propose adequate mitigation measures.
Ensure adherence to
GMP, GEP, GAMP5, and relevant regulatory guidelines .
Support
deviations, CAPAs, and change controls
in the context of qualification projects.
Coordinate and/or execute
FAT/SAT
activities and support validation tasks.
Contribute to continuous improvement of processes, standards, and CQ strategies.
About you
Degree in
Pharmaceutical Sciences, Chemical/Process Engineering, Biotechnology , or a comparable field.
Several years of experience in
Commissioning & Qualification
within the pharmaceutical industry.
Strong technical knowledge in
process equipment, utilities, cleanrooms, or filling processes .
Solid understanding of
GMP regulations , EU/FDA requirements, and modern science- and risk-based qualification approaches.
Proficient in working with technical documentation and quality systems.
Analytical, structured mindset with excellent communication and teamwork skills.
Very good command of both
English and German
Willing to travel
Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
Seniority level Mid-Senior level
Employment type Full-time
Job function Consulting
Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing
#J-18808-Ljbffr