Senior Validation Engineer I

Job Description

Description:

The Senior Validation Engineer I is ensures the reliability, consistency, and compliance of processes, test methods, equipment, areas and systems to meet regulatory requirements and quality standards. This position is responsible for defining the quality assurance and validation strategy for new and sustaining efforts, as well as developing and executing validation protocols and reports. The Sr. Validation Engineer I is also responsible for identifying manufacturing process improvements, performing risk analysis using tools such as pFMEA and provide support on compliance investigations. Requirements:

Duties and responsibilities

Generate and execute validation protocols to support processes, test methods, computerized systems, and equipment. This includes establishing strategy, performance criteria, equipment troubleshooting, and ensuring compliance with safety and quality standards.

The evaluation of engineering systems, of new and existing processes and equipment, to ensure the company is operating in a state of control.

Support company’s Master Validation Plan (MVP) including commissioning activities and protocols executions and establishing re-validation criteria.

Collaborate with other departments to evaluate engineering systems and processes.

Use engineering analytical skills to develop and monitor process and equipment metrics to be used for optimization analysis.

Measure and analyze equipment and processes data to ensure highest product quality.

Develop and execute process risk assessment (pFMEA) in order to identify potential risks associated with manufacturing processes and implement appropriate mitigation measures to minimize those risks effectively.

Support compliance investigations, risk assessments, and recommend corrective and preventive actions, as needed.

Responsible to support company’s change control program to ensure changes to the quality system are evaluated for risk and are performed in a controlled manner.

Support compliance investigations and recommend corrective and preventive actions.

Other duties as assigned.

Education Required:

Bachelor’s degree in engineering or a related technical discipline.

Experience Required:

Previous experience as a quality engineer, validation engineer or a similar role.

Prior experience creating validation strategies and utilizing risk analysis tools such as pFMEA.

At least 5 years’ experience in FDA regulated industry such as pharmaceutical, biotechnology, medical devices, or HCT/P manufacturing.

Strong analytical, planning, critical thinking, troubleshooting, and problem-solving skills.

Ability to effectively communicate with multidisciplinary teams.

Excellent technical writing.

Experience Preferred:

Preferred background in microbiology.

Experience in biopharma manufacturing operations, including cleanroom environments. Aseptic processing and cleanroom qualifications a plus.

Familiarity with relevant industry standards for sterile product including ISO standards for sterilization, packaging, and cleanrooms. (ISO 11137, ISO 11607, ISO 14644, ISO 14698, ISO 11737).

Familiarity with USP test methods for sterility testing and bioburden enumeration a plus.

Experience with laboratory equipment qualifications, and lab analytical methods validations.

Knowledge of current Good Manufacturing Practices for Biologics, Devices, and Tissues.

Licenses/Certifications:

ASQ CQE or Certified Tissue Banking Specialist (CTBS) certification preferred.

Working conditions

Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move objects weighing up to 30 pounds.

Direct reports

This role does not have any direct reports.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time.

Vivex Biologics, Inc is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training.

Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.

Full-time