Validation Engineer

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is looking for a strong Validation Engineer with lab and QC experience who will support our clients on a variety of compliance initiatives.

Primary Responsibilities

Advising clients on assigning proper risk to Lab Equipment and Instruments.
Advising clients on how to meet compliance requirements.
Advising clients on developing test that provide adequate compliance coverage as well as thoroughly tests business requirements.
Performing validation of Laboratory Instrumentation by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA compliance requirements.
Update Requirements, Functional, and Design Specifications.
Develop Installation Qualifications based on Design.
Develop Operation Qualifications based on functional requirements.
Develop Performance Qualification scripts based on configuration.
Perform test execution or lead execution activity.
Route validation documentation.
Manage Tasks based on aggressive timelines.
Interact with customers at multiple sites.
Interact in team environment.

Qualifications

Validation experience with lab equipment and lab systems in the pharmaceutical industry.
Minimum 3 to 5 years in pharmaceutical industry, focusing on Validation.
Experience with a variety of equipment that may include HPLC, GC, Spectrophotometers, UV-VIS.
Experience with a variety of lab systems that may include Empower, Chemstation, SDMS, ELN
Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice.
Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
Strong technical background.
Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
Ability to work independently with minimal supervision and adhere to timelines.
Quick learner.
Expert in MS Word.

Education & Certifications

University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Travel to client site for onsite work as needed.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.