Key Responsibilities:
Collaborate with C&Q Engineers to develop, review, and maintain commissioning and qualification procedures and documentation.
Write, review, and approve C&Q protocols and reports for various systems, including HVAC, utilities, production, and laboratory equipment.
Plan, coordinate, and execute commissioning and qualification activities for plants and equipment.
Manage project timelines, resources, and deliverables, ensuring alignment with client expectations.
Coordinate with external consultants and internal teams to ensure timely document generation and protocol execution.
Oversee change controls and deviations related to plant operations and equipment performance.
Support maintenance and calibration functions to enhance compliance and operational quality.
Provide technical expertise for troubleshooting, root cause investigations, and continuous improvement initiatives.
Facilitate the transfer of technical knowledge across units, departments, and sites.
Qualifications / Requirements:
Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or related scientific discipline.
Minimum of 2 years of experience in GMP manufacturing and C&Q activities within the biotech or pharmaceutical industry.
Strong knowledge of regulatory requirements, GMP standards, and quality systems.
Proven project management skills, including planning, coordination, and execution of technical projects.
Excellent analytical, problem-solving, and communication skills.
Ability to work effectively in a collaborative, cross-functional team environment.
Proficiency in English; additional language skills are a plus.
Preferred Skills:
Experience with FDA, EMA, or other regulatory inspections.
Familiarity with software tools used in C&Q documentation and project management.
Strong organizational skills and attention to detail.
Top Skills
What We Do
MENTOR Technical Group is a team of highly educated, superior trained, and dedicated professionals with expertise and experience to provide a complete portfolio of technical support and solutions for the FDA-regulated industry. MENTOR Technical Group delivers solutions with a flexible cost-effective approach to meet your company’s needs. Our purpose is to help you bridge the gap between your business strategies and results, by balancing three major aspects: People, Regulatory and Compliance, and Technology.
MENTOR Technical Group’s objective is to deliver reliable tailored solutions—from consultation to becoming part of your staff. This proximity helps us develop customized frameworks to help you unlock the hidden value in your plants, facilities, equipment, and staff, while optimally integrating resources, regulations, and technology.
MENTOR Technical Group’s commitment begins by getting involved from the conceptual phase up to the implementation phase of your projects. Our management staff has unparalleled experience in both the operating and consulting industries. We have over 200 technical staff members, which allows for efficient project execution.
At MENTOR Technical Group, we deliver on our commitments—every time, on time. Our enthusiastic highly skilled workforce consistently meets or exceeds client expectations. We don’t just perform for our clients; we work with integrity. Our professional staff takes pride in their work and acts with a sense of ownership.
