Equipment Validation Specialist

4 days ago


Concord, North Carolina, United States BioSpace, Inc. Full time
Job Title:

QC Equipment Validation Specialist

About the Role:

We are seeking a highly skilled QC Equipment Validation Specialist to join our team at BioSpace, Inc. This is an exciting opportunity to work in a dynamic environment and contribute to the development of our quality control laboratory.

Key Responsibilities:

Author equipment qualification/validation protocols and strategies for the QC Laboratories.

Provide support for equipment relocation and qualification associated with Concord Lab master plan.

Participate/lead in data integrity controls and improvement initiatives.

Technical review and execution of qualification/validation protocols.

Recommend and specify equipment purchases based on user requirements.

Communicate with other functions and external vendors regarding qualification issues and key operational objectives.

Act as liaison between the maintenance team and lab personnel to schedule preventative and corrective maintenance of equipment.

Responsible for design and execution of laboratory CSV initiatives, System Administrator duties, system upgrades, and data integrity.

Apply knowledge of quality principles, GMPs, federal regulations, corporate standards and practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management.

Interact effectively with customers, support groups and development.

Network with other areas to understand best practices, share knowledge, participate in global meetings and web seminars, and to ensure customer needs are met.

Influence improvements and streamline quality systems relating to equipment.

Serve as equipment expert and technical resource in the review of technical documents.

Act as subject matter experts and originator of change controls.

Investigate TrackWise CAPA records.

Interact with Global Quality Lab Equipment function to set global corporate policy regarding equipment.

Ability to multitask, prioritize and coordinate work to meet customer's needs.

Demonstrate problem solving and investigative skills.

Ability to make decisions based on knowledge, experience, best practices and requirements.

Ability to work independently and accurately with minimal supervision.

Requirements:

Bachelor's degree in a science or engineering related field (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)

5 or more years of laboratory experience with emphasis on laboratory equipment.

Experience supporting laboratory equipment in a GMP environment.

Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.

Understanding of compliance requirements and regulatory expectations for lab systems.

Preferred Qualifications:

Previous experience with managing data integrity regulations and controls.

Working knowledge of CMMS, Kneat, Empower, TrackWise, LabVantage LIMS, Veeva.

Ability to work cross-functionally.

Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering and IT personnel.

Additional Information:

Ability to work 8 hour days - Monday through Friday.

Ability to work overtime as required.

Limited travel may be required during project phase.

BioSpace, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles.

Learn more about all of our groups.

#WeAreBioSpace

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