Qualifications2–6+ years of experience working on capital or expense projects in the Pharmaceutical, Biotech, or Medical Device industry. BS in Engineering preferred (Chemical, Mechanical, Biomedical, or related).2+ years of experience in a cGMP environment required. Experience supporting CQV activities for process equipment, critical utilities, and tank farm systems, including protocol generation, execution, review, and summary reporting. Hands-on experience with CQV protocol generation, execution, review, and summary reporting preferred. Experience supporting qualification and validation activities for critical utilities, process equipment, and/or tank farm systems preferred. Strong understanding of pharmaceutical manufacturing processes and the ability to apply process engineering principles to project execution. Ability to provide both CQV and process/MSAT engineering support, with a willingness to work across disciplines based on project needs. Self-starter with strong communication skills, both verbally and in writing. Ability to work with and build good relationships with stakeholders and wider site teams. Ability and desire to work within a high-performing team and collaborate effectively and respectfully with internal and external staff at all levels and of diverse backgrounds. Previous consulting or owner-side project experience preferred. Ability to work up to 100% on-site at client facilities. Willingness and ability to travel up to 25%.
Requirements:
This individual will contribute to our strategic efforts to grow Concuir while providing technical project execution support across process engineering, MSAT, and CQV activities. They will also be responsible for the following:
Deliver on client expectations and maintain strong stakeholder communication throughout the project life cycle.
Perform Capital and/or Expense project deliverables in alignment with project timelines, budgets, and objectives.
Provide a balanced combination of process/MSAT engineering and CQV support, adapting to project and client needs.
Generate, execute, review, and summarize CQV protocols for process equipment, critical utilities, tank farm systems, and other project systems within scope.
Support qualification and validation activities from planning and protocol development through execution, documentation, issue resolution, and final reporting.
Provide process engineering support alongside CQV activities, including technical assessments, equipment evaluations, process troubleshooting, and manufacturing support.
Facilitate team communication and accountability by escalating issues appropriately.
Participate in cross-functional teams dedicated to process improvement, efficiency, and optimization.
Support technology transfer, construction activities, and scale-up efforts with strong technical documentation and writing.
Provide technical assessments for investigations, validation, and change control.
Review vendor submittals and technical documentation to ensure alignment with project design and user requirements.
Coordinate with project partners during equipment installation to ensure readiness and adherence to design intent.
Participate in troubleshooting and start-up of process equipment and utilities.
Generate and revise engineering specifications to support process equipment and manufacturing operations.
Execute studies and comparability protocols for manufacturing operations.
Foster a collaborative, inclusive team culture consistent with company values.
Consistently model Concuir’s core values.
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