Piper Companies is seeking a Sr. Validation Engineer in Philadelphia, PA to work for a global pharmaceutical company. The project is scoped to be 12 months with possibility for extension.
- Participates in system design and commissioning project phases.
- Provides oversight and technical guidance for Facilities, Formulation/Fill, and Packaging engineers during Installation and Operational Qualification.
- Generates Validation Project Plan for complex projects and systems
- Supports Risk Assessments documentation including but not limited to, System Impact Assessments, Components Criticality Assessments, Data Integrity Assessments and Automation Risk Assessments
- Authors Validation Protocols and Reports for cleaning, sterilization, computer/automation, shipping and method processes.
- Authors Validation Protocols and Reports for Controlled Temperature Units.
- Supports Periodic Assessments on required frequency intervals
- Performs Revalidations on required frequency interval
- Resolves technical issues encountered during study execution
- Schedules resources to approve and execute validation documents
- Participating in SOP development as needed
- Supports equipment start-up, shakedown, and cycle development
- Interacts with regulatory agencies during inspections to speak to validation program and questions related to process validation life cycle
- Implements/maintains governing cGMP procedures
- Ensures training of employees and contractors to assure up-to-date knowledge of practices and procedures
- Author and review change control documents
Responsibilities of the Validation Engineer include:
- Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
- Assist with SOP review and upgrades
- Supports the execution of equipment qualifications and validation protocols
- Thorough understanding of test method validation and updates
- Proven IQ/OQ/PQ work experience
- Supports calibration, equipment qualification and validation activities
Qualifications for the Validation Engineer include:
- 5+ years experience in equipment validation
- Regulated industry experience, medical device preferred
- Install/implement validation processes
- IR machine experience
- Understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
- Strong working knowledge of 21 CFR Part 11 compliance
- Ability to interact effectively across departments
Compensation for the Validation Engineer includes:
- $55-$65/hr on a contract rate
- Full Benefits Package including medical, dental, vision, 401K, and paid time off