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 world’s leader in providing inspection, verification, testing and certification services, Forbes ranked the SGS Group as one of the world’s top multinationals and one of the world’s 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
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
Directly reports to the Sr. Manager, Computer Systems Validation and Compliance
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• 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.
EDUCATION AND EXPERIENCE
• Bachelor’s 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
Strong asset to have over 5 years administering laboratory instruments and laboratory software applications
KNOWLEDGE / SKILLS / ABILITIES
• Language Skills: English Intermediate/Advanced/ required
• Mathematical Skills: Intermediate preferred
• Reasoning Skills/Abilities: Advanced preferred
• No travel required.
PHYSICAL DEMANDS OF THE JOB
Physical/Sensory Demands Frequency Requirements:
• Stand - Frequently
• Move or traverse - Frequently
• Sit - Frequently
• Use hands - Frequently
• Reach with hands and arms - Frequently
• Climb or balance - None
• Stoop, kneel, crouch or crawl - Frequently
• Talk/hear - Constantly
• Taste/Smell - None
• Lift/carry/push or pull - Occasionally
• No special vision requirements
• No special auditory requirements
• Low-Exposure: Has an indirect role and no access to operations where failure could result in serious harm to public or employee well-being, Group assets or the environment.
WORK CONDITIONS / EXPOSURE TO ENVIRONMENTAL CONDITIONS
Environmental Conditions Requirements:
• Wet or humid (non-weather) conditions - None
• Work near moving mechanical pats - None
• Work in high, precarious places - None
• Fumes or airborne particles - None
• Toxic or caustic chemicals - None
• Outdoor weather conditions - None
• Extreme cold (non-weather) - None
• Extreme heat (non-weather) - None
• Risk of electrical shock - None
• Work with explosives - None
• Risk of radiation - None
• Vibration - None
• Bio-hazard – None
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.
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 company’s 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 201-508-3149 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.