Validation Specialist

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Bio Stem Technologies (OTC: BSEM)

Job Type

Full-time

Description

Why Bio Stem Technologies:

Bio Stem 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, Amnio

Wrap2, and others, we empower clinicians to deliver superior outcomes.

Validation Specialist/ Tissue Allograph Manufacturing

Department:
Quality Control

Position Summary:

We are seeking a detail-orientedValidation Specialistto 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:

• Ensure all validation activities comply with applicable industry standards, regulations (e.g., FDA, ISO, GMP), and internal procedures.
• Participate in audits and inspections by regulatory authorities and support remediation efforts for non-compliance.

Risk Assessment and Documentation:

• Identify, assess, and mitigate risks associated with equipment and systems during the validation process.
• Create and maintain detailed, accurate, and up-to-date documentation for all validation activities.
• Review test results, identify deviations, and support troubleshooting and corrective actions.
• Work closely with cross-functional teams such as, Quality, Operations, IT, and R&D to ensure validation processes are aligned with production and business needs.
• Provide guidance and training to internal teams on validation procedures and requirements.
• Contribute to the continuous improvement of validation processes and practices.
• Monitor system performance and ensure any changes are properly validated (e.g., change control, revalidation).
• Suggest improvements to systems or processes based on validation outcomes.

Software Validation:

• Lead the validation of software applications and systems, ensuring that they meet the required standards and specifications.

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:

• Strong knowledge of validation methodologies (IQ, OQ, PQ).
• Familiarity with regulatory guidelines (e.g., FDA, GMP, ISO 13485).
• Experience with validation of manufacturing equipment, software systems, or laboratory instruments.
• Problem-solving skills and ability to conduct root cause analysis.
• Strong technical writing and documentation skills.
• Proficiency in software tools related to validation and testing (e.g., validation software, Microsoft Office Suite).

Preferred Qualifications:

• Experience with automated systems validation.
• Experience in a regulated industry (e.g., pharmaceutical, biotechnology, medical device).
• Certification in validation or related areas (e.g., Certified Quality Engineer, Certified Validation Professional).

Working Conditions:

• Ability to work in a regulated, fast-paced environment.
• Ability to lift and move equipment or tools as required.
• Some travel may be required to assist with validation activities at different sites.

Bio Stem 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
  
  Mid-Senior level

• Employment type
  
  Full-time

• Job function
  
  Quality Assurance
• Industries Biotechnology

Referrals increase your chances of interviewing at Bio Stem Technologies (OTC: BSEM) by 2x