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About the Role
This role involves working with a team of engineers on the design, commissioning, qualification, start-up, and project management of various processes, systems, and facilities within the biopharmaceutical industry. The Jr. CQV Engineer will focus on validating upstream and downstream bioprocess systems/equipment and process equipment in pharma/biotech industries, requiring leadership skills to guide intermediate and junior engineers.
Responsibilities
- Provide technical guidance in the commissioning, qualification, and start-up of pharmaceutical/biopharmaceutical cGMP process equipment, utilities, and facilities.
- Lead the development of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ, and PQ during the project lifecycle.
- Perform field execution of qualification test cases and protocols.
- Support the development of Project Validation Plans (PVPs).
- Lead qualification processes throughout the project lifecycle to ensure timely completion and adherence to quality and engineering specifications.
- Possess knowledge of relevant regulatory requirements and industry best practices for process equipment, clean utilities, automation systems, laboratory equipment, and facilities.
- Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates.
- Engage other departments in design reviews and decisions.
- Travel occasionally for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
- Provide occasional support during shutdowns or extended hours during installation, construction, commissioning, qualification, and validation phases.
- Visit construction and installation sites, wearing necessary safety PPE.
- Engage in client management, project scheduling/budgeting, coordination of resources, business development support, and industry presentations/publications.
- Supervise contractors during critical system and equipment testing.
- Perform other duties as assigned by client or MMR.
- Comply with client safety rules, including mandatory vaccination policies for COVID-19, where applicable.
Requirements
- 2-4 years of experience in commissioning, qualification, or validation of systems within the pharmaceutical/biotech industry.
- Previous experience in the pharmaceutical/biotech industry with knowledge of cGMP operations requirements.
- Engineering degree, preferably in Mechanical, Electrical, or Chemical.
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills.
- Ability to lift 50 lbs.
Skills
- Commissioning
- Qualification
- Validation
- Upstream bioprocess systems
- Downstream bioprocess systems
- Process equipment validation
- Leadership
- cGMP
- DQ
- FAT
- SAT
- IQ
- OQ
- PQ
- Project Validation Plans (PVPs)
- Process equipment
- Clean utilities
- Automation systems
- Laboratory equipment
- Building & facilities
- Client management
- Project scheduling
- Budgeting
- Business development
- Risk-Based Commissioning & Qualification approaches (e.g., ASTM E-2500, ISPE ICQ)
- Process control systems (PCS, SCADA, Historians)
- Building automation systems
- Biotech process equipment (fermentation, bioreactors, chromatography, TFF, UF, CIP systems, Buffer systems, Clean Utilities)
- Qualification/Validation of clean utilities and ISO clean rooms
- URS
- RTMs
- Risk Assessments
- CPPs
- VPPs
Location
- Greater Denver/Boulder Colorado & surrounding areas
Work Type
- Onsite
- Full-time
Experience Level
- Junior
Education Level
- Engineering degree
Salary/Compensations
- 80,000$ - 115,000$
About the Company
- MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries.
- Services include Engineering, Project Management, and Validation.
- MMR Consulting has offices in Canada, USA, and Australia.
Equal Opportunity
- MMR Consulting is an equal opportunity employer.
- We celebrate diversity and are committed to creating an inclusive environment for all employees.
- Our hiring decisions are based on merit, qualifications, and business needs.
- We are committed to working with and providing reasonable accommodations to individuals with disabilities globally.
- As part of our recruitment process, we may use technology-assisted tools, including AI-enabled systems, to support application review and candidate evaluation.
- Hiring decisions are made with human oversight and consideration.