Senior Computer System Validation Engineer

Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.

We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today’s world, it’s never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services. Compli is full services Commissioning, Qualification, Regulatory Compliance and On Demand services firm.

Essential Functions:

• Responsible for the Computer System Validation, 21 CFR part 11 audits, FMEA, Data Integrity assessments, project execution, project leadership
• Expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).
• Expertise in ERP, SAP, LIMS, and analytical validation
• Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.
• Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply.
• Other duties as assigned.

Education & Experience:

• Bachelor’s degree in scientific or engineering discipline along with 8 plus years of experience in the field of computer validation.
• Ideal candidate will have:
  • Information Systems validation experience
  • Equipment Automation validation experience (HPLC’s, DCS, SCADA, etc.)
  • Experience and knowledge of CSA
  • Laboratory Systems validation experience (LIMS)
  • Experience working with higher level systems including: TrackWise and ERP.

Technical Skills & Abilities:

• Considered a Subject Matter Expert (SME) in terms of qualification for at least one type of system, preferably Delta V. Individual will work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.
• Demonstrate expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards.
• Candidates must have excellent verbal communication and technical writing skills.
• Experience with all pertinent industry best practices (e.g., ISPE GAMP) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
• Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.
• Experience in Project execution within at least one area of systems validation – e.g., SAP/ERP, laboratory equipment, information systems.
• Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
• Ability to plan and manage own work

Travel:

• Willing to travel anywhere in the US for extended on-site services.