Job Details
**IT Lab Systems Support Specialist - Lincolnshire, IL**
* 616 Heathrow Dr, Lincolnshire, IL 60069, USA
* Full-time
**Company Description**
Make an impact with SGS! With more than 97,000 employees and 2,600 offices and laboratories across the world, SGS is a silent force working hard behind the scenes to deliver quality and integrity to businesses across nine industries. As the worlds leader in providing inspection, verification, testing and certification services, Forbes ranked the SGS Group as one of the worlds top multinationals and one of the worlds most innovative companies. The Dow Jones Sustainability Index has also recognized the SGS Group for its sustainability processes. In North America, SGS employs over 5,000 team members across serveral locations
**Job Description**
**SUMMARY**
Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment and execution of validation protocols
Data integrity and compliance to 21CFR Part 11 and GxP standards
**REPORTING LINE**
Directly reports to the Sr. Manager, Computer Systems Validation and Compliance
**A day in the life of a** **Pharmaceutical Laboratory Applications Support Specialist - IT at SGS US:**
* Install/update/troubleshoot instrument software and malfunctions, requires MS Windows/network troubleshooting skills
* Review and pilot testing of new software and instrument systems as part of system implementations
* Review and remediate non-compliance and audit issues for data integrity compliance on the computerized systems in the lab
* Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment and execution of validation protocols
* Data integrity and compliance to 21CFR Part 11 and GxP standards
* Prepare draft and final SOPs and compliance documents
* Liaise with and management activities of laboratory instrument and software vendors
* Develop validation protocols where not provided by vendor
* Review and recommend changes to improve efficiency of automated systems
* Install/update/troubleshoot instrument software and malfunctions, requires MS Windows/network troubleshooting skills
* Review and pilot testing of new software and instrument systems as part of system implementations
* Review and remediate non-compliance and audit issues for data integrity compliance on the computerized systems in the lab
* Prepare draft and final SOPs and compliance documents
* Liaise with and management activities of laboratory instrument and software vendors
* Develop validation protocols where not provided by vendor
* Review and recommend changes to improve efficiency of automated systems
* Adheres to internal standards, policies and procedures.
* Performs other duties as assigned.
#INDIT
**Qualifications**
**EDUCATION AND EXPERIENCE**
* Bachelors degree in Science, IT, Engineering or equivalent experience
* Experience should include the pharmaceutical laboratory systems such as Waters Empower and/or Open Lab CDS systems, Agilent, Waters, Thermo Fischer with typical instrumentation such as GC, HPLC, ICP-MS, MS/MS, Spectrophotometers, FTIRs
* Experience in instrument software setup, configuration and qualifications in a GxP / biological laboratory environment.
* Experience in troubleshooting Windows and network related issue with instrument software configurations
* LIMS Systems administration and configuration
* Working knowledge of GxP regulations and regulatory standards for computer systems validations
**Preferred:**
Strong asset to have over 5 years administering laboratory instruments and laboratory software applications
**Additional Information**
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
Please note that candidates applying for US job openings should be authorized to work in US.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the companys rights to assign or reassign duties and responsibilities to this job at any time.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-###-#### for assistance and leave a message. You will receive a callback. Please note, this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.
**In the course of employment, you will be required to travel to and/or work at a client site. The company requires employees to be vaccinated against COVID-19 in order to travel commercially and many clients require visitors performing work at their locations to be vaccinated. Therefore, this role requires a candidate who is fully vaccinated or will be prior to an anticipated start date. The successful candidate will be required to provide proof of having received a COVID-19 vaccination.**
**Job Location**
IT Lab Systems Support Specialist - Lincolnshire, IL
* 616 Heathrow Dr, Lincolnshire, IL 60069, USA
* Full-time