Analytical Validation Scientist For Laboratory Instrumentation

East Syracuse, NY

Posted: 07/12/2022 Job Number: 21090669

Job Description

*This position requires up to 5% of travel.
**Requires routine entry into laboratories to access instrumentation which requires appropriate levels of personal protective equipment (PPE).
***Frequent repeated motions such as bending, twisting, squatting, sitting, walking, and reaching is required with occasional lifting (up to 50lbs)

Required Skills:
  • BS in relevant area with 7 years' experience or MS degree with 4 years' experience or PhD with limited or no experience in the biopharmaceutical industry.
  • Experience with laboratory instrument qualifications
  • Must have applied knowledge and understanding of regulatory requirements for lifecycle management of analytical instrumentation and CSV, including cGMP, 21 CFR Part 11 and Data Integrity.
  • Develop Computerized Laboratory Instrument Validation and Qualification documentation including, Validation Plans, User and Functional Requirement Specifications (URS/FRS), Risk Assessments, Design Qualification (DQ) Protocols, Installation and Operational Qualification Protocols (IQ/OQ), Performance Qualification (PQ) Protocols, Traceability Matrices, Configuration Specifications, and Validation Summary Reports.
  • A working understanding of six sigma/lean principles. Excellent project management, communication, and technical writing skills are required.
  • Professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
  • Ability to take initiative, prioritize objectives for multiple projects, and adhere to scheduled timelines while maintaining flexibility.
  • Contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals is essential.
  • This position is based indoors, and you will be primarily working with others, however, will also work independently and alone at times.

Project Description:
  • Manage the implementation and upgrades for computerized and non-computerized analytical systems and instrumentation.
  • Responsible to plan, manage, and execute the start-up, commissioning, validation and qualification of new analytical instrumentation and systems, complete validation impact assessments for projects and develop and maintain validation master/project plans.
  • Coach junior scientists, laboratory analysts and contractors as well as provide technical expertise for project stakeholders and support network led validation projects.
  • Develop Qualification documentation for non-computerized systems.
  • Work closely with laboratory Subject Matter Experts (SME) to solve technical problems, identify worse case scenarios, and gain insight into the specific use of each instrument subject to qualification activities.
  • Support Network Quality Control (NQC) Instrument Lifecycle Team in executing network led qualification projects.
  • Drive the completion of qualification activities onsite while working with cross-functional teams.
  • Track validation project schedules and milestones.
  • Communicate progress effectively and escalate technical and logistical concerns promptly.
  • Maintain familiarity and current knowledge of United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopeia (JP) for the major tests run in the QC and Microbiological Control (MC) Laboratories.
  • Support Instrument Comparability Studies with MST and laboratory qualification and implementation teams.
  • Review vendor supplied qualification protocols for technical content ensuring the protocols meet the Client and Regulatory requirements.
  • Maintain safe working environment throughout the implementation and qualification process.
  • Follow company policies and procedures
  • Operate instrumentation during installation and operational qualifications.
  • Record/review data using good documentation practices.
  • Conduct investigations as required.
  • Writing, revising, or reviewing SOPs, training materials and change requests.
  • Serve as SME during regulatory and internal inspections and ensuring timely completion of requests generated during them.
  • Evaluate and assess change controls request and make recommendation following validation services SOPs.

This 8+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren: loren@alphaconsulting.Com


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Loren Graham

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