Senior CQV Project Leader & Coach

Quality Agents, LLC; Rockville (MD); On-site; USD 125,000 - 165,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

AD&D insurance

Disability insurance

401k retirement plan

Paid time off

Paid holidays

Paid parental leave

Health savings account

Job summary

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. The Lead Consultant manages the full project lifecycle and owns the project-level client relationship, leading project teams while still doing hands-on work. Travel to client sites is required.

Typical experience ranges from 6 to 10+ years in qualification, validation, or related QC fields. Compensation includes a comprehensive benefits package and bonus potential.

Qualifications

• BS in a technical discipline (Engineering, Chemistry, Microbiology, Biology).
• Typically 6 to 10+ years of experience in equipment/utility qualification, process validation, analytical method validation, or cleaning validation.

Responsibilities

• Manage the full project lifecycle for qualification and validation projects: write validation master plans, coordinate project meetings, and see packages through to closure.
• Lead commissioning and qualification activities for facility, utility and equipment start-ups from design to acceptance testing and reporting.
• Write, review and execute validation plans, IQ/OQ/PQ protocols and SOPs for equipment, systems and utilities.
• Travel to client sites as projects require.
• Lead the project team: daily direction, quality review of deliverables, and coaching engineers.

Skills

Problem solving

Technical writing

MS Office

Validation equipment knowledge

Statistical analysis

Communication skills

Education

BS in a technical discipline

Tools

Kaye validator

Wireless data loggers

Job description

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. The Lead Consultant manages the full project lifecycle and owns the project-level client relationship, leading project teams while still doing hands-on work. Travel to client sites is required.

Typical experience ranges from 6 to 10+ years in qualification, validation, or related QC fields. Compensation includes a comprehensive benefits package and bonus potential.