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Lab Systems Validation

4 months ago

Exton, United States Planet Technology Full time

Lab Systems Validation & Applications Team Lead – (Full-Time/Perm) – Onsite – PA

Award-winning CRO seeks Lab Systems Validation & Applications Team Lead to assist with the operations of 25+ lab systems within a full-time/perm onsite role. Experience required includes having defined and maintained lab systems computer validation programs, while leading system implementations, validation, administration, data management, and user support, while ensuring GxP requirements are met. This person will require 10 years pharma or equivalent Lab IT and GxP regulated environments. Additionally, this person must have hands-on skills within the areas of CSV; LIMS, ELN and IDBS, and analytical lab instruments. A history of project management is key. Opportunity offers generous base compensation, bonus and benefits within an organization that has enabled many biotech and pharma organizations to advance within regulatory environments both nationally and internationally.


Benefits:

  • Competitive base salary.
  • 10% annual performance-based bonus.
  • Full Health, Dental and Vision Insurance (Aetna).
  • 401K with up to 6% employer contribution and match.
  • 4 weeks’ vacation.
  • 8 holidays.
  • Life Insurance.
  • Short and Long-Term Disability.
  • Continuing Education Allowance.
  • Local candidate preferred but relocation provided based on individual location and requirements.
  • Ability to be onsite 5 days a week.


Responsibilities

  • Leading global lab computer systems validation program to ensure both business needs and regulatory GxP requirements are met.
  • Leading and managing the Computer Systems Validation Team.
  • Providing validation support for DMPK, Bioanalytical, Biologics, Clinical, and IT.
  • Leveraging efforts in validation across multiple sites and within enterprise computer systems as needed.
  • Providing support, guidance, and training for validation projects.
  • Maintaining validated state of software throughout periodic reviews, change control, implementations and upgrades as needed.
  • Assisting with client and FDA audits as necessary.
  • Ensuring computer inventory of systems and software is maintained and accessible.
  • Proving application support for lab systems to include Watson LIMS, IDBS E-Workbook, Empower, and others.
  • Resolving user issues and providing solutions while then explaining and training.
  • Evaluating and implementing new software technologies as needed.
  • Supporting user account accessibility (account set-up and application access).
  • Managing and liaising with lab systems vendors to resolve and escalate issues.
  • Providing support for instrumentation qualification and software validation to include enhancements, administration of lab instruments and other software related.
  • Supporting lab software configurations as related to lab instrumentation.
  • Ensuring completion of documentation in support of software alterations and upgrades.
  • Driving system improvements and efficiency ensuring business improvements and compliance throughout.
  • Contributing to change controls and procedures regarding lab software specifically.
  • Coordinating, interfacing and hosting vendors while onsite and when applicable.
  • Serving as point-of-contact between Lab Groups and Corporate IT, while communicating and liaising accordingly.
  • Providing training on software functionality, while ensuring thorough understanding.
  • Ensuring software applications are validated to 21 CFR Part 11 when required, and always maintained within validated state.


Requirements

  • US or Green Card Work Authorization; located ideally local to southeastern PA or willing to relocate locally.
  • Bachelor’s degree in similar field and 10+ years in pharmaceutical industry.
  • Hands-on knowledge of the following:
  • Computer systems validation principles and methodology.
  • Commercial LIMS/ELN platforms to include but not limited to LabVantage, Watson, LabWare, Nugenesis, IDBS and more.
  • Major analytical instrumentation expertise to include Empower, LC/LCMS, and others.
  • Strong project management and people management skills, with a history of this.
  • GxP regulatory environment expertise, having worked within computerized analytical systems and data integrity prior.
  • Expertise within lab systems to include LIMS, IDBS, Empower, NuGenesis or others.
  • Strong leadership, organizational, planning and communication skills set.