CQV Consultant

Hallam-ICS; Apex (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Hallam-ICS in Apex, NC is seeking an experienced Commissioning, Qualification & Validation (CQV) Consultant to serve pharmaceutical, biotechnology, medical device, and other regulated life sciences clients. This client-facing role combines technical leadership, project management, and business development.

You will build client relationships, identify and shape new opportunities, develop scopes and proposals, and lead CQV projects from planning through execution and closeout.

Qualifications

• Bachelor’s degree or equivalent in engineering or life sciences.
• 4+ years in commissioning, qualification, validation, or related delivery.
• Experience leading projects with scope, schedule, budget, and client communication.
• Knowledge of cGMP, IQ/OQ/PQ, and the qualification lifecycle.

Responsibilities

• Lead CQV projects from planning through execution and closeout.
• Develop scopes and proposals for client opportunities.
• Provide technical direction to multidisciplinary teams.
• Foster client relationships and grow CQV presence in NC region.

Skills

Project leadership

Client relationships

Proposal development

CQV lifecycle

Regulated facilities

Travel readiness

Education

Bachelor's degree in Engineering/Life Sciences/Construction Management

Job description

We currently have an opening for an experienced Commissioning, Qualification & Validation (CQV) Consultant in our Apex, NC office serving pharmaceutical, biotechnology, medical device, and other regulated life sciences clients. This client-facing role combines technical leadership, project management, and business development. You will build client relationships, identify and shape new opportunities, develop scopes and proposals, and lead CQV projects from planning through execution and closeout. You will also provide technical direction to multidisciplinary teams and help grow Hallam-ICS’s CQV presence throughout North Carolina and the surrounding region.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Construction Management, or a related technical discipline, or equivalent relevant industry experience.
• 4+ years of demonstrated experience in commissioning, qualification, validation, engineering, or life sciences project delivery.
• Experience leading projects with responsibility for scope, schedule, budget, resources, quality, and client communication.
• Strong communication and client relationship skills and the ability to identify needs, develop solutions, and translate opportunities into scopes of work and proposals.
• Experience developing technical proposals, estimates, schedules, staffing plans, and project execution strategies.
• Knowledge of cGMP, Good Documentation Practices, and the qualification lifecycle, including commissioning, startup, functional testing, IQ/OQ/PQ, deviation resolution, and turnover.
• Experience with HVAC, cleanrooms, utilities, process equipment, automation, controlled environments, or facility support systems in regulated facilities.
• Ability to lead multidisciplinary teams, mentor junior staff, and manage multiple projects or client accounts.
• Existing relationships in the North Carolina life sciences market and familiarity with ASTM E2500, ISPE guidance, or GAMP 5 preferred.
• Ability to travel to client sites and participate in client meetings, site visits, proposal presentations, and industry events as required.

A pre-employment drug screening and background check are required.

Hallam-ICS is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.