Biopharma Validation Specialist

Quality Agents, LLC; Rockville (MD); On-site; USD 50,000 - 105,000; Full time

Benefits offered by this job

Health, dental and vision insurance

Life, AD&D and disability insurance

Health savings account

401k retirement plan

Paid time off

Paid holidays

Paid parental leave

Incentive bonuses

Job summary

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our consultants support the qualification and requalification of equipment, utilities, systems and facilities used to manufacture and test biologics and drug products at client sites and provide GMP quality assurance support to client quality organizations.

The Consultant builds technical skills under direct supervision and grows into independent work on standard deliverables, acting

Qualifications

• BS in a technical discipline (Engineering, Chemistry, Microbiology, Biology).
• Current driver's license and auto insurance, or other dependable means of transportation.
• Typically, 0 to 4 years of experience in equipment/utility qualification, process validation, analytical method validation, or cleaning validation.

Responsibilities

• Write and execute qualification protocols (IQ, OQ, PQ) for biopharmaceutical equipment, systems and support utilities in accordance with SOPs, validation master plans, regulatory expectations and industry standards.
• Conduct temperature mapping studies, including the operation of Kaye data loggers or equivalent.
• Review documented test results and maintain records for later analysis.
• Assist with non-conformances, investigations and troubleshooting of equipment, utilities and systems.
• Read P&IDs, isometric drawings and as-built drawings.
• Work closely with client site manufacturing, engineering and QA personnel to develop validation documents.
• Support commissioning and start-up activities such as system walkdowns, factory and site acceptance testing, and design and requirements reviews.
• Gain exposure to the validation aspects of facility start-up, redesign, retrofit and expansion.
• Travel to client sites and complete assigned tasks on schedule.
• Comply with all applicable Quality Agents and client policies on health, safety and the environment.

Skills

Problem solving

Technical writing

MS Word

MS Excel

MS PowerPoint

MS Project

Kaye data loggers

Statistical analysis

Communication skills

Education

BS in a technical discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Kaye validator

Job description

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our consultants support the qualification and requalification of equipment, utilities, systems and facilities used to manufacture and test biologics and drug products at client sites and provide GMP quality assurance support to client quality organizations.

The Consultant builds technical skills under direct supervision and grows into independent work on standard deliverables, acting