Location : Valley Cottage NY US 10989
Job Type : Direct
Reference Code : 20420-MK1
Compensation : 70000.00 - 90000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for a Quality Engineer responsible for leading and executing validation activities in a fast-paced cGMP manufacturing environment.
- Review and approve executed qualification and validation documents for facilities, processes, and equipment.
- Prepare and review validation protocols and reports (e.g. IQ, OQ, PQ), ensuring compliance and adherence to the design, customer and internal quality requirements.
- Conduct and participate in deviation investigations to identify root causes and define corrective and preventative actions (CAPAs).
- Organize engineering runs and validation activities with cross-functional teams to meet project objectives.
- Lead training of cross-functional teams involved in validation.
- Support the review and evaluation of system design requirements (e.g. URS) and design phase implementation initiatives (e.g. FAT/SAT).
- Represent Quality in cross-functional teams.
- Support process and product improvement initiatives and analyze product performance to identify trends as necessary.
- Support the evaluation of existing system modifications to evaluate risk, and establish and implement a qualification strategy.
- Interact with European design centers to ensure that design transfer and validation practices align with global requirements.
- Drive technical quality activities to completion in accordance with project objectives and timelines.
- Support document creation or revisions as needed.
Required Qualifications :
- BS Engineering
- Minimum 5 years in Quality related role, with validation experience.
- Experience from design conception through commercial implementation (e.g. URS, DQ, FAT, SAT, IQ, OQ, PQ) desired.
- Demonstrated ability to apply problem-solving methodology to identify the root cause and implement solutions.
- Experience data collection and statistical data analysis (e.g. capability analysis).
- Knowledge and experience with Change Controls, CAPAs, Quality Risk Management, FMEA.
- Applied Knowledge of Computerized System Validation (CSV) and Data Integrity Principles is desired (e.g. GAMP5 and 21 CFR Part 11).
- Experience in Facilities related validations is desired (e.g. Cleanrooms).
- Ability to comprehensively document and communicate validation requirements and deviations encountered.
- Experience with quality engineering concepts such as statistical analysis, quality testing, sampling and inspection, process control. Minitab and SAP knowledge a plus.
- Knowledge of ISO, GMPs, 21CFR Part 211 and/or 820 regulations.
Contact: Monique Kleiman