Senior Computer System Validation Engineer
Senior Computer System Validation Engineer
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$ 120000 - 175000
1 Vacancy
Job Description
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 todays world its 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 inhouse 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 project leadership
- Expertise in current and emerging cGMP requirements and quality trends (e.g.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:
- Bachelors 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 (HPLCs 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 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 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 onsite services.
Salary Range:
- $120000 to $175000 per year.
Its more than just a job
At Compli we are about innovative and intelligent people who want to solve problems. Were known for our technical excellence but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.
At Compli we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age race religion color sex national origin marital status genetic information sexual orientation gender identity gender expression disability veteran status pregnancy status or any other status protected by law.
Required Experience:
Senior IC
Employment Type
Full-Time
