Summary of Primary Responsibilities:
Leads start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device, and drug product manufacturing processes.
- Leads the delivery of validation within complex, capital projects overseeing engineering, quality, and compliance aspects of validation.
- Authors, executes, and summarizes qualification and validation protocols.
- Conducts Risk / Impact assessments and establish system boundaries.
- Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
- Coordinates the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or validation.
- Initiates, or provides validation input on quality systems such as CAPAs and change controls.
- Responsible for other duties and projects as assigned.
The job requires the ability to work on diverse complex issues where analysis of situations or data requires an in-depth evaluation of a variety of factors. The position exercises broad judgment in selecting optimum methods, techniques, and evaluation criteria for obtaining results. The job may require coordination of activities of other personnel such as contractors/specialists/interns to support validation assignments (Team Lead).
Experience, Knowledge, and Skills Required:
- Bachelor’s Degree in Engineering or Scientific discipline. Post-graduate coursework may be expected.
- 5-8 years of validation experience in pharmaceutical, medical device or FDA regulated environments.
- Strong understanding of cGMP and regulations related to facility, utility, equipment, and process validations.
- Ability to initiate, manage and close quality systems such as change control, CAPA and deviation management.
- Detailed experience performing root cause analysis investigations for deviations and non-conformances having technical scope.
- Excellent written and verbal communications skills.
Desired Experience, Knowledge, and Skills:
- Advanced degree or post-graduate coursework may be desirable.
- Solid understanding of quality risk management principles and statistical concepts as applicable to area of responsibility.
- Subject matter expert on regulations and best practices pertaining to validation.
- Practical application and knowledge of ISO 13485, GHTF Process Validation Guidance and other applicable standards used in the medical device manufacturing.
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.