Validation Engineer III

This position is responsible for documenting Laboratory Equipment Qualification / Validation studies, specifically pertaining to Quality Control.

Prepare drafts of the protocol and technical report documentation for review with subject matter experts, project staff and/or customers.

Edit, standardize, or revise material prepared by other writers or subject matter experts.

Create and revise protocols and technical reports for Laboratory Equipment Qualification (IQ, OQ, and PQ) with input from subject matter experts and according to company policies.

Assist multiple teams of technical experts in the technical writing of Laboratory Equipment Qualification

Prepare binders containing all relevant documentation. Organize documentation and cross-reference documents as necessary.

Route final documents for the appropriate approvals.

Revisions of Laboratory Equipment Qualification documentation must be done utilizing defined content and formatting requirements. Ensure cGXP compliance in all documentation.

Investigate and document non-conformances in a timely manner.

Able train on and follow company SOP documentation standards, templates and practices.

Work in compliance with cGMPs.

Additional Responsibilities

Incorporate new material or information while understanding its implications.

Work independently under minimal supervision and direction.

Work effectively across organizational and functional boundaries

Skills:.

Excellent writing and editing skills and must write in a concise and easy-to-read manner

Proficient with MS Office Applications

Experience with HPLC, Dionex, GC, LCMS, UVVis Spectroscopy and empower software

Familiarity with 21CFR part 11 validation automation systems is required.

Bachelor's degree with 6-9 years in biopharmaceuticals or Life Sciences OR Master s degree with 4-7 years in biopharmaceuticals or Life Sciences

2 years experience working in cGMP environment

Regards,

Akriti Gupta

Associate Recruiter

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3409 | Fax: 973.998.2599

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