JOB TITLE: Validation Engineer
DEPARTMENT: Quality
POSITION REPORTS TO: Vice President of Quality
SALARIED:
BASIC PURPOSE OF POSITION:
Develop and evaluate manufacturing processes and systems and perform validation testing to ensure compliance with standards and regulations. Technical quality assurance resource for all Operations and QA areas. Analyzes existing operations against the requirements of ISO 13485 and 21 CFR: 820 and proposes enhancements in compliance with those operations, to those regulations. Provides guidance on solutions to moderately complex problems.
ESSENTIAL FUNCTIONS/DUTIES:
- Coordinating and directing validation activities.
- Measuring production processes and parameters against internal and industry standards.
- Drafting technical protocols and reports to support validation activities.
- Establishing validation standards and developing performance testing and quality control measures.
- Analyzing test data.
- Presenting validation test results and recommending improvements.
- Maintaining master validation planning records.
- Provide technical expertise for new product development and sustaining production.
- Support development and implementation of risk management activities such as Hazard Analysis and FMEA.
KEY WORKING RELATIONSHIPS:
INTERNAL: Must be able to work as part of an interdisciplinary team, interacting easily with the members of the team. Must be able to support the ongoing manufacturing of products. Must be able to provide technical consultation to other personnel in a positive, supportive way.
EXTERNAL: Must be able to work with outside vendors in support of product production and testing. Must be able to interact with customers in solving customer problems. Must be able to work with external auditors.
SUPERVISORY RESPONSIBILITIES:
EDUCATION AND EXPERIENCE REQUIREMENTS:
- Bachelor’s or Master’s Degree in Engineering, Microbiology, Chemistry or related field
- Must have 2-3 year of validation experience in medical device or pharmaceutical production/manufacturing environment.
- Must be proficient in the use of office automation software including MS Word and Excel.
PREFERRED QUALIFICATIONS:
- Experience with ISO 13485 regulations and FDA GMP and QSR
- Multilingual (English and Spanish are a plus)
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
