GMP Systems Administrator

Come join our family! Microbac Laboratories is an essential business offering competitive pay and benefits including medical, dental, vision, life insurance, disability, generous paid time off including vacation, holidays and flex-time, a wellness program, referral bonus, tuition reimbursement and more!

Whether you are just starting your career in science or looking to further it, Microbac will put you on the path of an exciting career with room to grow. Quality, safety, giving back to our communities, diversity and inclusion, customer success and employee wellbeing are part of our core culture. We are looking for motivated individuals to join our family as a GMP Systems Administrator.

ABOUT MICROBAC

Microbac Laboratories, Inc. is a premier commercial laboratory testing firm that partners with clients worldwide, offering laboratory solutions to the life science, food and nutrition, and environmental industries and serves our clients with the utmost expertise and respect for their market requirements, constraints, and challenges. We embody a company-wide commitment to exceptional customer experience, which has been refined over nearly 50 years of trusted, analytical and measurement experience.

Through our network of laboratories, offices, and field services, we have the flexibility to meet the unique requirements for each client, project, and scope.

As a privately held third-party testing company, Microbac operates with a commitment to safety, quality, and compliance. Our diverse work portfolio includes broad accreditation offerings and tested insights across the environmental, food and nutrition and life science markets.

JOB SUMMARY

Microbac is seeking a GMP Systems Administrator to take ownership of all GMP software validations and lab IT system compliance activities across our regulated laboratory environments. This role is essential in ensuring that all computerized systems-including laboratory instrumentation software-are validated, maintained in a state of control, and fully compliant with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5).

The ideal candidate will have deep experience in GMP software validation, supporting laboratory instrument systems, and preferably hands-on familiarity with chromatography data systems (CDS) such as Chromeleon, or equivalent.

This role bridges IT systems administration with quality and regulatory oversight, working closely with laboratory staff, QA, and vendors to implement and maintain compliant, validated systems fit for use in a GMP environment.

This is a six-month position, with potential for full-time employment.

Essential Functions:

• Lead and execute full-cycle GMP software validation activities (IQ, OQ, PQ) for laboratory computerized systems, including chromatography data systems, LIMS, and standalone instrument software.
• Maintain system validation documentation per internal SOPs and applicable regulatory requirements.
• Act as SME for computerized system validation (CSV), supporting audits, inspections, and CAPAs.
• Ensure lab systems and instrument PCs are secure, validated, properly backed up, and maintained in a compliant state.
• Manage the configuration, deployment, and qualification of laboratory instrument software (e.g., HPLC, GC, UV, etc.).
• Collaborate with QA and Lab Managers to assess validation impact for software and hardware changes.
• Provide Tier 2/3 technical support for lab-based systems, escalating as needed.
• Implement and maintain backup and restoration strategies for all GMP systems.
• Assist in periodic review of GMP systems, including user access review, audit trail checks, and performance monitoring.
• Maintain system inventories and validation status records.
• Support computerized systems lifecycle activities: URS development, risk assessments, vendor assessments, change control, and decommissioning.
• Work with vendors on system upgrades, patches, and service contracts while ensuring ongoing validation and compliance.
• Support internal and external audit readiness related to computerized systems.
• Provide end-user training and SOP documentation related to validated systems.

Minimum Requirements:

• Bachelor's degree in Computer Science, Information Systems, Life Sciences, or related technical field.
• 5+ years of experience with GMP computer systems, including performing or leading software validation.
• Proven experience with FDA 21 CFR Part 11, GAMP 5, and related guidance.
• Strong technical skills in system administration, particularly with lab-based instrument PCs and software.
• Familiarity with chromatography systems (e.g., Empower, Chromeleon, OpenLab) strongly preferred.
• Ability to write clear, thorough, and compliant validation documentation (IQ/OQ/PQ, protocols, reports).
• Experience with backup/recovery processes for regulated systems.
• Working knowledge of Active Directory, Group Policy, Windows Server, and networking basics.
• Strong problem-solving skills and the ability to work independently and cross-functionally.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Experience supporting laboratory IT infrastructure and analytical instrumentation (HPLC, GC, etc.).
• Familiarity with Microsoft 365 environment and basic cybersecurity best practices.
• Experience with LIMS or other lab data management systems.
• Knowledge of software change control and configuration management practices in regulated environments.
• Experience working in an FDA-regulated (GxP) laboratory.
• Familiarity with remote IT support tools, virtualization (VMware/Hyper-V), and enterprise backup solutions.

WORKING CONDITIONS AND PHYSICAL REQUIREMENTS

The physical demands and working conditions described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements:

• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools; talk or hear. The employee is occasionally required to stand, walk, and sit.
• The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include color vision and depth perception.

Working Conditions:

• The noise level in the work environment is usually moderate.
• This job may require travel less than 20%

As a privately held third-party testing company, Microbac operates with a commitment to safety, quality, and compliance. Our diverse work portfolio includes broad accreditation offerings and tested insights across the environmental, food and life science markets.

OTHER:

This job description is not an exhaustive list of all duties an employee may be required to perform. Microbac reserves the right to revise the job description at any time.

Employment is at-will. Microbac, promotes a drug-free, alcohol-free workplace. Applicants considered for hire must pass a drug test before beginning work. Refusal to submit to testing will result in disqualification of further employment consideration.

Microbac is an Equal Opportunity Employer - We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. All qualified applicants will receive consideration for employment.