Project Manager

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries.

Our Project Managers will oversee the qualification and requalification of equipment used to manufacture and test biologics, drug products, etc. at client sites. The Project Manager will evaluate the equipment, utilities, systems and procedures used in development, production, and holding of pharmaceutical products and determine a validation approach. The individual should have experience with current US and international regulations, guidance, industry best practice in one of the following areas of validation: facilities, utilities, and equipment qualifications, process validation, analytical method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. The Project Manager is also responsible for client relations at the job site, including but not limited to on-going assessment of current client needs in order to offer solutions and services to the client and will seek and solicit prospective clients as well.

Responsibilities include:

Write validation master plans related to specific projects and coordinate project meetings related to execution of the validation master plan. Write validation site specific and multi-site procedures. Support implementation of validated systems change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies and manufacturing documentation review and approval. Available to travel nationally and internationally.

Present Quality Agents service offerings to prospective clients

Constantly seek new client opportunities

Participate in the integration, installation, testing, validation and deployment of new applications and systems

Write, review, and/or execute validation plans, IQ/OQ/PQ protocols and SOPs for equipment

Serve as system administrator with responsibility for user account maintenance

Troubleshoot and resolve equipment issues at various client sites

Drive communication with clients and serve as primary point of contact for cleaning, manufacturing and validation issues

Perform risk assessments to determine criticality and impact of user reported issues

Participate in sponsor and regulatory audits.

Maintains up-to-date knowledge of validation requirements, practices and procedures.

Participate as lead for facilities upgrades and major construction projects

Cleaning validation and verification

Sterility validation, medial fill

Process Validation of biological process

Filter and method validation

Skill Level and Requirements:

Able to problem solve and troubleshoot.

Understand existing and new business processes and requirements to ensure proper implementation and validation of systems

Thorough knowledge of 21 CFR Part 11, Annex 11, GAMP5, 21 CFR Part 58 and industry best practices.

Strong technical writing skills

Proficient in Microsoft Word, Excel, Power point, and Project

Proficiency with validation equipment such as the Kaye validator, wireless data loggers, or other monitoring devices is strongly desired.

Able to read P&ID, Isometric and "As Built" drawings.

Experience performing IQ/OQ on large automated systems/process equipment and the computerized system lifecycle associated with it

FAT experience with large automated systems

Experience using statistical tools is a plus to analyze data captured during validation studies.

Minimum Requirements:

BS in a technical discipline (Engineering, chemistry, microbiology, biology) or equivalent work experience

10+ years of experience in management and validation.

Current driver’s license and auto insurance

Quality Agents offers a full suite of benefits for full-time employees including:

Health, dental and vision insurance

Life, AD&D and disability Insurance

Health savings account for participants in our health plan

401k retirement plan

Paid vacation

Paid sick leave

Paid holidays

Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.