Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at USAMRIID . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.
We are currently seeking a Validation Engineer for the Frederick, MD area. This position for a Lead Validation Engineer/ Scientist is part of USAMRIID’s expansion of its capabilities to perform Medical Countermeasure (MCM) Advanced Test & Evaluation (T&E) to facilitate approval of biomedical products by FDA.
Management and continuing improvement of the Institute’s established equipment qualification and software validation program.
Incumbent will manage, and support, and provide guidance to all Qualification/ Validation activities for the operations of existing USAMRIID regulated laboratories, including those at biocontainment levels BSL-2, BSL-3, and BSL-4.
Management execution of the commissioning and qualification/validation program as it pertains to GLP Labs, Equipment and Utilities, and Validation Maintenance.
Provide expert technical guidance and Lead, support, oversee the conduct of Installation Qualification, Operational Qualification, Performance Qualification (IQ, OQ, PQ) procedures to support the validation process in a regulated environment
Oversee the development, review, and approval of qualification/ validation protocols
Assist in cross functional projects from development through IND submission;
Manage Execute activities in support of the Institute Validation Working Group priorities;
Provide technical assistance during investigations of equipment and software issues as needed;
Prepare and maintain validation records;
Provide guidance to ensure Maintain electronic data readability of identified GLP equipment/software over the retention period of the equipment/ software.
Incumbent will be expected to work in biocontainment environments (i.e., BSL-2, -3, and BSL-4, as needed), and meet requirements under the Army Personnel Reliability Program.
Development, execution, data analysis and reporting of validation and qualification activities for laboratory instrumentation to meet GLP requirements.
Employ a risk-based approach to qualification and validation activities Support / perform risk assessments as well as periodic assessments for various systems to fulfill requirements for details that include a validation maintenance program.
Under general supervision, review and provide authorization when justified for proposed changes to qualified/ validated systems. Identify the qualification/ validation requirements necessary to maintain the system’s validated status.
Track and report to testing facility management on status of qualification/ validation activities and assists Chief, Regulated Studies on capital improvement initiatives.
Provide validation metrics and business analyses for budget and resource planning to division management and above as required.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
Performs light duties and other related duties as required and assigned.
Contractor shall have at least B.S. in Chemical or Mechanical Engineering or similar scientific discipline, with 3 years laboratory experience in the pharmaceutical industry.
Preference will be given to candidates with relevant equipment qualification/validation experience in the pharmaceutical industry.
Ability to perform independently with minimal direction
Must be able to work independently following a brief period of specific technical training.
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.
ClinicalRM is an Affirmative Action-Equal Opportunity Employer
“NorthCoast 99” Best Places to Work recipient
Clinical Research Management - 2 years ago
ClinicalRM is a Contract Research Organization supporting government and commercial clinical research for biologics, drugs, and devices.