Under the direct guidance of the Operations Validation Engineer Manager, the Junior Validation Engineer is responsible for implementing, documenting, validating, and preparing equipment and procedures used in development and production of Cerapedic’s products. They will ensure all systems are validated and running according to necessary specifications and requirements as set forth by current regulatory bodies (i.e. FDA, BSI, etc.). The Junior Validation Engineer will have knowledge of industry standards and regulatory guidelines.
Specific Functions and Responsibilities:
Processes & Equipment Validation / Enhancements:
- Proactively develop best practices and innovative solutions to improve manufacturing processes with regards to sustainability, efficiency, and regulatory compliance in order to meet Cerapedics short- and long-term strategic goals and projected commercial growth.
- Develop and execute equipment and process qualification and validation studies according to FDA Quality System Regulations, ISO 13485 requirements, and Cerapedics SOPs. Write study protocols, analyze data, and write study reports.
- Ensure all process and equipment activities are properly documented in a timely manner.
Risk & Overall Support:
- Participate with risk management activities including process and product risk planning and risk assessment.
- Assist with the personnel training program with regards to providing the appropriate education for new or revised processes and equipment.
- Assist with various cross-functional projects, as necessary.
The above description outlines the most common job duties; however, it does not exclude other potential work assignments.
Education or Formal Training Required:
- College degree with 3-5 years of relevant experience
Qualifications Required: (knowledge, skills, abilities, initiative, judgment, etc.)
- Previous experience in medical device industry
- Ability to work independently, plan and prioritize
- QSR/GMP & ISO Quality System experience
- FDA validation experience
- Good writing skills
- Ability to work as a team player
- Strong interpersonal skills
- Strong decision-making skills
- Adaptable to various job duties as necessary in a small company
- Good computer and word processing skills
Work Conditions / Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully preform the essential functions of the job. Reasonable accommodations may be made when requested by the employee to enable individuals with disabilities to perform the essential functions.
- This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.
- This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs.
- This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination.
Travel requirement: < 5%
Benefits/Compensation (including but not limited to)
Medical and dental insurance, group life insurance, 401k matching, long term disability, potential target bonus, paid time off.
Salary Range: 70-80k
We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.