Company: AP Professionals of Rochester
Posted on: February 23, 2021
DESCRIPTIONAP Professionals has partnered with a medical company
that is looking to add both a Junior and Senior Validation Engineer
to their growing team. The Validation Engineers will ensure
regulatory compliance through developing and executing validations.
Produce validation reports and develop and update procedures, work
instructions, and forms. Knowledge and experience in IQ/OQ/PQ
required. This is a full-time, direct hire role that offers room
- Develop and maintain the Master Validation Plan.
- Develop and execute protocols supporting the Facility, Utility,
and Cleanroom Qualification, Equipment Qualification, Process
Validation, Cleaning Validation, and Test Validation.
- Collaborate with other departments in order to develop
strategies to test and validate the performance and reliability of
equipment and processes.
- Perform qualification testing in accordance with internal
protocols/procedures or external standards and regulatory
- Analyze validation test data to determine whether systems or
processes have met validation criteria and support investigation
into root cause of problems.
- Produce validation reports such as statistical analysis,
results analysis, observations, and conclusions.
- Oversee technicians performing validations and mentor/train
less experienced personnel on validation methodology.
- Understand, communicate, and follow current Good Manufacturing
- Work with cross functional teams on projects relating to
various validation topics and maintain an open and cooperative
relationship in order to stay involved and promote teamwork.
- Develop and update procedures, work instructions, and
- Assist with internal/external Quality System Audits.
- Identify and implement improvements for existing processes
(Corrective and Preventative Actions-CAPA).
- Support facility, utility and operations related
non-conformance reports (NCRs); root cause and corrective actions
with a goal towards reduction and prevention.
- Maintain accurate and compliant documentation to meet company,
and regulatory expectations.
- Support and adhere to the Quality Policy and Quality System
- Associates or Bachelor's Degree in an engineering, technical or
- Certification in Project Management, Auditing or other
validation related certification a plus.
- A minimum of 2 - 10+ years' validation experience is required
depending on level.
- Detailed knowledge of IQ,OQ, PQ and ISO 13485 required.
- Knowledge in validation and statistical tools such as Sampling
Plans, Experimental Design and Optimization is desired.
- Knowledge of current and applicable GMP regulations is
required. Knowledge of FDA Quality System Regulations (QSR) and
International Organization for Standardization (ISO) requirements
and/or regulations is required.
- Knowledge or experience with quality audits preferred.
KNOWLEDGE, SKILLS, ABILITIES, AND OTHER CHARACTERISTICS
- Ability to manage multiple projects simultaneously.
- Excellent Communication skills, both oral and written.
- Proficient in MS Office, MS Project, Minitab Statistical
- Familiar with creating Project Plans and organizes resources to
ensure project milestones are met within expectations of timeline,
quality, and budget.
Keywords: AP Professionals of Rochester, Rochester , Validation Engineer, Engineering , Rochester, New York
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