FacilitiesUtilitiesHVAC Lead

We are looking for a CQV Lead with expertise in production equipment such as isolators bioreactors fume hoods BSCs and TCUs. The candidate will be responsible for protocol development and to ensure production equipment meets operational and regulatory standards.

Key Responsibilities:

Develop and execute commissioning qualification and validation protocols for production equipment.

Coordinate with equipment vendors for FAT/SAT activities and ensure integration into facility systems.

Oversee equipment calibration performance verification and doentation.

Lead risk essments to identify and mitigate potential equipment compliance risks.

Provide crossfunctional support for other CQV efforts within the project.

RequirementsQualifications:

Bachelor s degree in Engineering Life Sciences or related field.

10 years of experience in validating production equipment in pharmaceutical environments.

Expertise in isolators bioreactors fume hoods and other lab equipment.

Strong knowledge of regulatory requirements and riskbased validation approaches.

Excellent project management and problemsolving ss.

At least 3 years experience/ knowledge with automated systems, including programming and improving complex systems Familiarity with at least one computer coding language (such as Python, Java, C#, HTML), understanding in version control systems (like GitHub or GitLab) is a plus Able to independently contribute through development and optimization of automation technologies preferred. Able to oversee implementation of automation technologies with third parties through technical ss and project management principles Must be able to work productively in an interdisciplinary team environment Experience with Hamilton, Scinomix, Tecan or similar automated laboratory platforms preferred Good oral and written communication, problem-solving, and ytical ss Ability to influence and educate other scientists and engineers to use automation technologies as part of implementation Proficiency using PC and Microsoft Office tools Excellent organizational and time management ss Strong attention to detail GMP and Good Doentation Practice Intermediate ss with WORD (authoring/editing large technical doents with styles, tables, TOCs, track changes) Basic ss with EXCEL and PowerPoint Experience with and tolerance for high levels of challenge and change Experience with project management including capturing project requirements and deliverables, timeline development, stakeholder management and communications

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