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Equipment Operations Scientist

Eurofins Lancaster Laboratories PSS is searching for an Equipment Operations Scientist in West Point, PA.

The position supports the operations team.

Equipment Operations Scientist responsibilities include, but are not limited to, the following:

  • Partnering with the laboratory end users, quality support, lab computing, and instrument vendors on implementing new instruments on site.

  • Directly supporting analytical instrument and analytical system validations.

  • Performing any validation change control during the life-cycle of the system

  • Performing system periodic review to update equipment master lists

  • Performing system decommissioning

  • Manage the Controlled Temperature Unit portfolio (includes installation, preventative maintenance, corrective maintenance, etc.)

  • Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable.

  • Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols, reports, addendums and other validation deliverables as required by the site validation SOPs.

  • Assist the system owner with evaluating recommending the appropriate user roles and privileges for data integrity (where applicable)

  • Ensures lab instrument's adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines.

    Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence.

    For systems found unable to fully comply, formulate workarounds/strategies with core stake holders to mitigate the gaps.

  • Initiates and leads risk assessment, gap analysis, and deviation management associated with validation of lab instruments.

  • Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument.

    Previous experience with PR/CAPA systems preferred.

  • Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.

  • All other duties as assigned.

  • Perform out of calibration (OOC)/out of tolerance (OOT) remediation

  • SOP author, reviewer

  • Able to understand and follow procedures

  • Familiarity with system validations and associated regulations

  • Participate in regulatory agency audits

The ideal candidate would possess:

  • Hands on experience operating instrument systems.

  • Demonstrated attention to detail.

  • Must be able to work independently.

  • Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.).

  • Demonstrated ability to work in a team environment and manage workload to meet deadlines.

  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

  • Ability to manage priorities sometimes on a fluid basis

  • Able to communicate effectively with bench scientists and lab users

Basic Minimum Qualifications:

  • Bachelor's degree in a science or engineering related discipline with knowledge in quality operations laboratory processes.

  • 2-4 years of experience in the validation of laboratory instruments including those with computerized systems attached in a cGMP environment.

  • 2-4 years of experience in the Pharmaceutical industry or relevant business experience within Quality Assurance or Validation cGMP Compliance.

  • Authorization to work in the United States indefinitely without restriction or sponsorship

Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed.

Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.

As a Eurofins Lancaster Labs employee, you will become part of a company that has received national recognition as a great place to work.

We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.

To learn more about Eurofins Lancaster Laboratories, please explore our website .

Eurofins Lancaster Laboratories is an Equal Employment Opportunity and Affirmative Action employer.

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