Amaris Consulting
C&Q - Project Engineer [F/M/X]
Amaris Consulting, Hickory, North Carolina, United States, 28601
Job DescriptionPosition Overview:
We are seeking a highly skilled Engineering & Consultancy Specialist to join our team, focusing on Manufacturing Automation and Maintenance C&Q and related life cycle activities. The ideal candidate will be responsible for a range of engineering and consultancy tasks, ensuring the successful execution of qualification and commissioning activities while maintaining high standards of quality and compliance.
Key Responsibilities:
Qualification & Commissioning Activities:
Write, execute, and coordinate all qualification and commissioning activities.
Review and assess documents within the department to ensure compliance and quality.
Technical Support:
Act as the technical owner for business support, addressing questions and technical issues as requested.
Provide detailed assessments for projects, changes, modifications, and non-compliance issues assigned by the C&Q lead.
Project Management:
Maintain up-to-date Kanban cards for project work overview.
Enter assessments and completed tasks in Trackwise.
Communication & Coordination:
Communicate with involved departments regarding test planning, materials, and resources.
Pass relevant project information to the qualification engineer and provide updates and support as needed.
Collaboration:
Support and guide qualification engineers in evaluating project issues and changes impacting qualification activities.
Work closely with qualification engineers to ensure timely and qualitative execution of qualification activities.
Document Review & Approval:
Review and approve qualification documents (URS, SRS, IA, DQ, QP, IQ, OQ, discrepancies, PQ, QSR, VMP, PSQR) prepared by qualification engineers.
Collaborate with the QA qualification team to secure approval for qualification files.
Quality Improvement:
Initiate and follow up on Quality Improvements (QIs) and corrections in Trackwise as needed.
Contribute to internal improvement projects within the C&Q team.
Training & Development:
Assist the C&Q lead in providing introductory qualification training (LDO) and onboarding for new team members.
Coach and provide feedback to qualification engineers regarding the quality of their work.
Inspection Support:
Assist the C&Q lead in preparing for and supporting internal and external inspections.
Help maintain the area Validation Master Plans and perform periodic assessments of GMP critical systems.
Kaizen Opportunities:
Identify quality catches and Kaizen opportunities, reporting them to the C&Q lead.
Qualifications:
Degree in Engineering, Life Sciences, or a related field.
Proven experience in qualification and commissioning activities within a regulated environment.
Process equipment experience.
Strong understanding of GMP and quality assurance principles.
Excellent communication and interpersonal skills.
Proficiency in project management tools and Trackwise.
Ability to work collaboratively in a team-oriented environment.
Amaris Consulting is committed to promoting diversity within its workforce and creating an inclusive working environment. We welcome applications from all qualified individuals, regardless of gender, sexual orientation, race, ethnic origin, creed, age, marital status, disability or any other characteristic.
#J-18808-Ljbffr
We are seeking a highly skilled Engineering & Consultancy Specialist to join our team, focusing on Manufacturing Automation and Maintenance C&Q and related life cycle activities. The ideal candidate will be responsible for a range of engineering and consultancy tasks, ensuring the successful execution of qualification and commissioning activities while maintaining high standards of quality and compliance.
Key Responsibilities:
Qualification & Commissioning Activities:
Write, execute, and coordinate all qualification and commissioning activities.
Review and assess documents within the department to ensure compliance and quality.
Technical Support:
Act as the technical owner for business support, addressing questions and technical issues as requested.
Provide detailed assessments for projects, changes, modifications, and non-compliance issues assigned by the C&Q lead.
Project Management:
Maintain up-to-date Kanban cards for project work overview.
Enter assessments and completed tasks in Trackwise.
Communication & Coordination:
Communicate with involved departments regarding test planning, materials, and resources.
Pass relevant project information to the qualification engineer and provide updates and support as needed.
Collaboration:
Support and guide qualification engineers in evaluating project issues and changes impacting qualification activities.
Work closely with qualification engineers to ensure timely and qualitative execution of qualification activities.
Document Review & Approval:
Review and approve qualification documents (URS, SRS, IA, DQ, QP, IQ, OQ, discrepancies, PQ, QSR, VMP, PSQR) prepared by qualification engineers.
Collaborate with the QA qualification team to secure approval for qualification files.
Quality Improvement:
Initiate and follow up on Quality Improvements (QIs) and corrections in Trackwise as needed.
Contribute to internal improvement projects within the C&Q team.
Training & Development:
Assist the C&Q lead in providing introductory qualification training (LDO) and onboarding for new team members.
Coach and provide feedback to qualification engineers regarding the quality of their work.
Inspection Support:
Assist the C&Q lead in preparing for and supporting internal and external inspections.
Help maintain the area Validation Master Plans and perform periodic assessments of GMP critical systems.
Kaizen Opportunities:
Identify quality catches and Kaizen opportunities, reporting them to the C&Q lead.
Qualifications:
Degree in Engineering, Life Sciences, or a related field.
Proven experience in qualification and commissioning activities within a regulated environment.
Process equipment experience.
Strong understanding of GMP and quality assurance principles.
Excellent communication and interpersonal skills.
Proficiency in project management tools and Trackwise.
Ability to work collaboratively in a team-oriented environment.
Amaris Consulting is committed to promoting diversity within its workforce and creating an inclusive working environment. We welcome applications from all qualified individuals, regardless of gender, sexual orientation, race, ethnic origin, creed, age, marital status, disability or any other characteristic.
#J-18808-Ljbffr