Validation Specialist

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Senior Human Resources Business Partner BioStem Technologies

Job Type

Full-time

Description

Why BioStem Technologies :

BioStem Technologies, Inc. is a regenerative medicine leader manufacturing placental-derived allografts for advanced wound care. Through our proprietary BioREtain technology and portfolio of trusted products like VENDAJE, AmnioWrap2, and others, we empower clinicians to deliver superior outcomes.

Validation Specialist / Tissue Allograph Manufacturing

Department : Quality Control

Position Summary :

We are seeking a detail-oriented Validation Specialist to support the qualification and validation of new processes and equipment. This position plays a critical role in ensuring compliance with regulatory standards by developing and executing validation protocols that support operational readiness, regulatory compliance, and product safety and efficacy.

You will be responsible for coordinating validation activities, authoring and reviewing validation documentation (IQ / OQ / PQ), and supporting process improvements. The ideal candidate is highly organized and experienced in navigating quality systems within the regulated life sciences industry.

Requirements

Key Responsibilities : Including but are not limited to the following, other duties may be applied.

Develop and Execute Validation Plans :

• Plan, develop, and implement validation strategies and protocols to verify the functionality and compliance of systems or equipment.
• Conduct IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) testing.
• Review and approve validation protocols and reports.

Compliance and Regulatory Requirements :

Risk Assessment and Documentation :

Software Validation :

Responsible for other duties and projects as assigned.

Qualifications :

Education : Bachelor's degree in engineering, Life Sciences, Computer Science, or a related field.

Experience

2-5 years of experience in validation engineering, quality assurance, or a related field.

Skills :

Preferred Qualifications :

Working Conditions :

BioStem Technologies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

The above assignments are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exclusive list of all responsibilities, duties and skills required. At the discretion of Management, Other duties and project may be assigned.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Industries

Biotechnology

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