Validation Engineer

About the role

The qualified candidate must have the experience and ability to participate in multiple projects within Site Technical Services (STS), Quality Control (QC), Quality Assurance (QA), Quality Laboratory Systems (QLS) and Business Technology (BT).

She/He perform a variety of validation activities to maintain the validation life cycle of laboratory instruments (e.g.,validation of new and legacy instruments, performance verification, calibration, software and hardware through change control, application support, LabWare interface and LabWare build creation). She/He will participate with LabWare build creation and interfacing LabWare with laboratory instruments.

Performs all work in compliance with cGMPs and site requirements.

• Perform instrument validation activities (creation and execution of validation documents, instruments performance verification, calibration, laboratory application support).
• Prepare laboratory reagents for use in instrument performance verification/calibration.
• Write and/or revise standard operating procedures for laboratory instrumentation and maintenance.
• Write and/or revise computer related system validation documents (e.g., validation plan, test plan, requirements specification, qualification protocols, and validation summary reports).
• Participate with Business Technology (BT) initiatives as applicable (e.g., DMS migration, firmware and software upgrade, serve as liason between QC labs and BT).
• Collaborate with QC Lab Systems in interfacing laboratory instruments with LabWare Enterprise system and Labware build creation.
• Ensures that work area is maintained in a neat, safe, orderly, and compliant manner. Suggests continuous improvements to systems, procedures, etc. Carries out technical and administrative duties as needed.

Qualifications & Requirements

BS in scientific discipline (e.g., Chemistry or Biology) or related field with 5-8 years or MS in Chemistry or Biology or related field with 3-5 years of industry experience, preferably in the pharmaceutical or biopharmaceutical industry.

• Extensive knowledge and practical application of relevant techniques - working with variety of QC laboratory analytical instrumentation [e.g., High Performance Liquid Chromatography, Gas Chromatography, variety of Spectrophotometers (UV-Vis, NIR, AAS, ICP, Plate Readers), Capillary Electrophoresis, imaging Capillary Electrophoresis, and others)].
• Demonstrated ability to independently develop, document, validate, and troubleshoot laboratory instruments of high levels of complexity.
• Proficiency with Empower, Labware LIMS, and MS Word Office Suite
• cGMP (CFR 211, ICH, Annex 15) experience.
• Candidate must be detail oriented with very strong verbal and written communication skills (e.g., technical writing skills, validation documents and etc.).
• Ability to work well in a team environment.
• Strong independent work skills to meet established deliverables (project management experience is a plus)
• Familiarity with Enterprise System (e.g., Quality Tracking System), and other laboratory applications (e.g., SoftMax pro, ImageLab, UV Probe, UV WinLab, Empower) is a plus.