Senior CQV Engineer / Senior Validation Engineer
A leading consultancy in the life sciences sector is seeking a Senior Validation Engineer to support a range of technical workstreams, including formulation, aseptic fill/finish, lyophilization, and utility systems. This role is ideal for a proactive professional with strong experience in commissioning and qualification (C&Q) of large-scale process equipment in regulated environments.
Role Overview
This position involves working across multiple systems and equipment types, requiring flexibility, technical depth, and the ability to work independently. The successful candidate will contribute to the development and execution of validation strategies, ensuring compliance with industry standards and regulatory expectations.
Key Responsibilities
- Follow established procedures and industry standards (GMP/GEP) to support qualification activities.
- Prepare and manage verification documentation in line with quality and regulatory requirements.
- Initiate and implement change controls and corrective actions for deviations and non-conformances.
- Participate in design reviews and mechanical completion walkdowns for utility systems.
- Author and execute verification testing protocols (VTPs) in the field.
- Support temperature mapping and calibration verification activities.
- Collaborate with cross-functional teams including Engineering, Quality, Automation, and Operations to define testing requirements and priorities.
- Contribute to continuous improvement of validation and change control processes.
Candidate Profile
- Education: Bachelor's degree in Engineering or a related technical field from an accredited institution.
- Experience: At least 4 years in engineering or project management, with a focus on utility verification and facility system qualification in regulated environments.
- Technical Skills:
- Strong understanding of cGMP and validation requirements.
- Experience in pharmaceutical or FDA-regulated manufacturing settings.
- Ability to develop and revise validation strategies and lifecycle documentation.
- Familiarity with execution of equipment verification protocols is essential for future project phases.
- Communication: Excellent written and verbal communication skills, including the ability to present technical information clearly.
- Work Authorization: All applicants must have the legal right to work in the United States without the need for current or future sponsorship.
Location Requirement: Only candidates based near Kalamazoo, MI will be considered.
Why Join This Team?
- High-growth, people-focused organization with a collaborative culture
- Comprehensive benefits package including healthcare, retirement plans, and paid time off
- Opportunities for professional development and continuous learning
- Supportive environment that values integrity, inclusion, and innovation
- Recognition programs and team-building activities
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