Job: Validation Associate, CoImmune Inc., Durham, NC
SCOPE: This is an onsite position located in Durham , NC. Prepare, execute, and summarize validation protocols and periodic reviews and assist in the development of other validation related documents (risk assessments, validation plans, trace matrix, specifications, etc.) to support new or existing systems used for or in support of GMP activities.
Write, execute, summarize and review validation protocols (IQ/OQ/PQ) and FAT/SAT protocols as required.
Assist in the resolution of deviations noted during protocol execution.
Analyze and summarize Periodic Reviews of previously validated systems, and develop/implement protocols/changes based on outcome of the review.
Assist user groups in troubleshooting and analyzing systems for research, process development, and cGMP processes and testing. Participation may include selection process for new systems to help improve work practices or product quality using previously obtained validation data.
Maintain system and validation inventory lists through periodic reviews and approvals.
Take part in the development of formal deviations and CAPAs as they relate to validation activities.
Assist in the development and maintain risk assessments, URS/FR/DS, validation plans, and trace matrices.
Follow departmental and company-wide SOPs and policies and assist in the revision of procedures.
Perform other miscellaneous duties as required
1+ year of validation experience in a biotech/pharmaceutical environment, with emphasis in laboratory systems, equipment, facility, utility, and/or computerized system qualification.
Bachelor's degree in a technical/science/mathematical field.
Strong written and oral communication skills with ability to interact with various individuals and roles throughout the organization and with external consultants.
Results oriented, self-motivated, self-starter with flexibility to adapt to changing priorities and ability to manage multiple projects/activities simultaneously.
Strong working knowledge of good documentation practices and FDA/EU regulatory requirements and guidance documents.
Good interpersonal, organizational and trouble shooting skills.
Strong ability and willingness to learn and work within a team environment.
Ability to lift up to 20 pounds.
Direct experience working in cleanrooms or sterile facilities is preferred, but not required.
Ability and willingness to be regularly, predictably, and reliably at work.
Please apply directly to: email@example.com