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. Due to our constant growth, we are looking for a full-time Senior Engineering Project Manager with 6+ years of experience fitting the following mandatory skill-set and willing to work in Mayenne, France . Responsibilities: Project management assistance: feasibility studies, preliminary design, detailed design Procurement assistance: preparation of tender documents, definition of specifications, choice of suppliers Construction management and coordination: planning, safety monitoring, financial monitoring Commissioning / decommissioning and qualification of machines (new or upgrades): monitoring of construction phases, preparation of test files Implementation & ramp-up management: lead execution, qualification (OPR), and performance monitoring Requirements: Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Automation, Industrial Engineering), or related fields Minimum of 6 years of experience in project management within the pharmaceutical, biotech, or medical device industries, particularly in packaging equipment, production lines, or similar environments Familiarity with industry-specific standards and regulations (e.g., GMP, EHS) Experience in feasibility studies, preliminary and detailed design, procurement, and supplier management Proven track record in managing complex projects, including feasibility, design, procurement, construction, and commissioning phases Strong technical knowledge in mechanical, electrical, automation, and software systems for packaging equipment Knowledge of Quality Management Systems (QMS) and familiarity with FAT, SAT, QI, and QO processes Fluent in French and English (both written and spoken) Certification in Project Management (e.g., PMP or Prince2) is a plus Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial Talent Acquisition interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback 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.
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. Due to our constant growth, we are looking for a full-time Process Engineer with expertise in Commissioning, Qualification, and Validation (C&Q) to join our team. The ideal candidate will have over 3 years of experience in C&Q, SAT (Site Acceptance Testing) for assembly and packaging processes in the Pharmaceutical or Medical Device industry. Location: Dunkirk, France . Key Responsibilities: SAT Testing: Plan, execute, and document Site Acceptance Testing (SAT) for assembling and packaging equipment, ensuring compliance with regulatory and quality standards C&Q Activities: Lead Commissioning, Qualification, and Validation (C&Q) activities, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) for new or modified equipment Technical Documentation: Develop and review technical documentation such as URS (User Requirement Specifications) , FRS (Functional Requirement Specifications) , SAT protocols , and validation reports Process Optimization: Collaborate with cross-functional teams to optimize assembling and packaging processes, ensuring efficiency and compliance with GMP standards Regulatory Compliance: Ensure all processes and equipment meet GMP , FDA , and EMA regulatory requirements Troubleshooting: Identify and resolve technical issues during SAT and C&Q activities, ensuring minimal disruption to operations Stakeholder Collaboration: Work closely with internal stakeholders, vendors, and contractors to ensure successful project execution and alignment with business goals Training: Provide training and support to operations and maintenance teams on new equipment and processes Qualifications: Education: Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) Experience: 3+ years of experience in the Pharmaceutical or Medical Device industries in C&Q , SAT testing , and process engineering, preferably in assembly and packaging operations Language: Fluency in French (written and spoken) is required. Proficiency in English is a plus Technical Skills: Strong knowledge of GMP , FDA , and EMA regulations; experience with SAT protocols , IQ/OQ/PQ , and validation processes; proficiency in technical documentation and risk assessment; familiarity with assembly and packaging equipment (e.g., fillers, labelers, cartoners) Soft Skills: Excellent problem-solving, communication, and project management skills Preferred Qualifications: Knowledge of purified water systems , sterile processes , or HVAC systems Certification in PMP or Six Sigma is a plus 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 feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback 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.
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.
Due to our constant growth, we are looking for a full-time Senior Engineering Project Manager with 6+ years of experience fitting the following mandatory skill-set and willing to work in Mayenne, France .
Responsibilities:
Project management assistance: feasibility studies, preliminary design, detailed design Procurement assistance: preparation of tender documents, definition of specifications, choice of suppliers Construction management and coordination: planning, safety monitoring, financial monitoring Commissioning / decommissioning and qualification of machines (new or upgrades): monitoring of construction phases, preparation of test files Implementation & ramp-up management: lead execution, qualification (OPR), and performance monitoring
Requirements:
Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Automation, Industrial Engineering), or related fields Minimum of 6 years of experience in project management within the pharmaceutical, biotech, or medical device industries, particularly in packaging equipment, production lines, or similar environments Familiarity with industry-specific standards and regulations (e.g., GMP, EHS) Experience in feasibility studies, preliminary and detailed design, procurement, and supplier management Proven track record in managing complex projects, including feasibility, design, procurement, construction, and commissioning phases Strong technical knowledge in mechanical, electrical, automation, and software systems for packaging equipment Knowledge of Quality Management Systems (QMS) and familiarity with FAT, SAT, QI, and QO processes Fluent in French and English (both written and spoken) Certification in Project Management (e.g., PMP or Prince2) is a plus
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial Talent Acquisition interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback 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.
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.
Due to our constant growth, we are looking for a full-time Process Engineer with expertise in Commissioning, Qualification, and Validation (C&Q) to join our team. The ideal candidate will have over 3 years of experience in C&Q, SAT (Site Acceptance Testing) for assembly and packaging processes in the Pharmaceutical or Medical Device industry.
Location: Dunkirk, France .
Key Responsibilities:
SAT Testing: Plan, execute, and document Site Acceptance Testing (SAT) for assembling and packaging equipment, ensuring compliance with regulatory and quality standards C&Q Activities: Lead Commissioning, Qualification, and Validation (C&Q) activities, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) for new or modified equipment Technical Documentation: Develop and review technical documentation such as URS (User Requirement Specifications) , FRS (Functional Requirement Specifications) , SAT protocols , and validation reports Process Optimization: Collaborate with cross-functional teams to optimize assembling and packaging processes, ensuring efficiency and compliance with GMP standards Regulatory Compliance: Ensure all processes and equipment meet GMP , FDA , and EMA regulatory requirements Troubleshooting: Identify and resolve technical issues during SAT and C&Q activities, ensuring minimal disruption to operations Stakeholder Collaboration: Work closely with internal stakeholders, vendors, and contractors to ensure successful project execution and alignment with business goals Training: Provide training and support to operations and maintenance teams on new equipment and processes
Qualifications:
Education: Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) Experience: 3+ years of experience in the Pharmaceutical or Medical Device industries in C&Q , SAT testing , and process engineering, preferably in assembly and packaging operations Language: Fluency in French (written and spoken) is required. Proficiency in English is a plus Technical Skills: Strong knowledge of GMP , FDA , and EMA regulations; experience with SAT protocols , IQ/OQ/PQ , and validation processes; proficiency in technical documentation and risk assessment; familiarity with assembly and packaging equipment (e.g., fillers, labelers, cartoners) Soft Skills: Excellent problem-solving, communication, and project management skills
Preferred Qualifications:
Knowledge of purified water systems , sterile processes , or HVAC systems Certification in PMP or Six Sigma is a plus
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 feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback 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.
