Position Summary
Responsible for providing guidance and conducting the equipment/process/test method validation to ensure regulatory compliance ( FDA, ISO 9001 and ISO 13485:2003 and other regulatory requirements) and effectiveness of facilities, equipment, test methods and processes.
Responsibilities
80% for the following activities:
1. Lead process validations, test method validations, process capability studies, and process improvements.
2. Write; execute IQ, OQ, PQ validation studies of equipment and processes, utilities, and software validations as specified in Validation Master Plans and protocols.
3. Ensure all validation activities are in compliance with ISO 13485 / GMP 21 CFR 820 / 21 CFR Part 11 and internal MSD procedures.
4. Participate in risk management of automated manufacturing processes and equipment.
5. Participate on technical project teams as subject matter expert on validation regulations/procedures.
6. Ensure that quality system inputs to the validation system are adequately addressed
7. Design process characterization studies, conduct statistical analysis of results using Minitab or equivalent to identify critical parameters and improve process capability.
8. Support continuous improvement activities for the validation program to ensure efficiency, effectiveness, and compliance.
9. Perform test method validation activities including equipment parameter studies.
10. Participate in development and implementation of sampling plans for in-process and final testing, inspections, and validations.
11. Identify and evaluate critical process parameters. Conduct studies, write protocols and reports in support of process validation activities
12. Participation in FDA inspections, ISO Certification and surveillance audits and customer and supplier audits.
13. Work with a cross-functional team to plan and execute validation protocols on new and existing equipment/Process and test methods.
20% on the following activities as requested
1. Application of the principles of performance evaluation and prediction to improve product/systems safety, reliability and maintainability.
2. Working with a cross-functional team to plan and execute reliability test protocols on new and existing systems.
3. Planning, tracking and analysis for reliability testing and field failures (including mathematical modeling to determine system reliability and MTBF/MCBF).
4. Participation in hazard analysis, FMECA, and risk mitigation.
5. Implementing root cause analysis and addressing CAPA entries.
6. Perform special projects on request.
7. Carry out other duties as required or assigned
Requirements
BS or MS degree in technical/scientific/engineering discipline, with at least 6-7 years of experience in production process, test method and Equipment Validation in a medical device-manufacturing environment., in vitro diagnostics, life sciences or a related industry. Applied technical understanding of manufacturing equipment and processes specific to medical device manufacturing.
Experience utilizing application of Advanced Quality tools, such as Failure Modes Effect Analysis (FMEA), SPC, Root Cause Analysis and process capability techniques in a manufacturing environment. Software Validation and 21CFR Part 11 compliance is a plus. Excellent working knowledge and experience of FDA's Quality System requirements (QSR) and ISO 9001, ISO 13485:2003 standard. Knowledge and experience with the Global Harmonization Task Force Guidance on Process Validations required. ASQ certification (CQE, CSQE, and CQA) is desirable.
- The candidate should have strong analytical, communication and interpersonal skills. Strong linguistic, grammar, and editing skills a plus. Ability to multi-task in an environment with changing priorities.
Proficiency with Microsoft applications Word, Excel, Project, and PowerPoint. And ability to learn additional software applications, as the need arise
:
Ø Medical PPO / Dental / Prescription / Vision Plans
Ø Health and Dependent Care Flexible Spending Accounts
Ø 401(k) Plan with Company Matching Contributions
Ø Short and Long Term Disability Insurance
Ø Paid Vacation Leave, Sick Leave, Holidays
Ø Extended Holiday Break
Ø Contribution to Fitness Club Membership
It is the policy and practice of the Company to offer equal employment opportunities to all qualified applicants and employees without regard to race, color, age, religion, national origin, sex, political affiliation, sexual orientation, marital status, disability, veteran status, genetics, or any other protected characteristic.
This policy applies to all areas of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoffs, compensation, benefits and all other terms, conditions and privileges of employment.
