AIQ (Analytical Instrument Qualification)

Omni Inclusive

• $80K — $120K *
Skaneateles, NY 13152In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • Bachelor's or Master's degree in Chemistry, Engineering, Life Sciences, or a related technical field.
  • Experience in analytical equipment qualification in a GMP-regulated medical device or pharmaceutical setting.
  • In-depth understanding of FDA regulations (21 CFR Parts 820, 210/211, 11).
  • Familiarity with GAMP 5 and ISO 13485 standards.
  • Knowledge of data integrity principles (ALCOA+).

Responsibilities

  • Serve as the technical subject matter expert for analytical equipment qualifications in manufacturing.
  • Author and execute qualification protocols in line with GAMP 5 and FDA regulations.
  • Lead lifecycle activities including equipment requalification and periodic reviews.
  • Ensure compliance with data integrity standards in systems linked to analytical instruments.
  • Collaborate across departments to set qualification strategies for new and upgraded equipment.
  • Maintain clear traceability between user needs and qualification deliverables.
  • Guide on change control processes for equipment modifications.

Benefits

  • Opportunity to drive continuous improvement in global qualification practices.
  • Engagement in cross-departmental collaborations to enhance qualification strategies.
  • Support for professional development through certifications, such as Lean Six Sigma.
  • Exposure to diverse projects across multi-site environments.
Full Job Description
Key Responsibilities:
  • Serve as the technical SME for qualification of analytical equipment in manufacturing setup
  • Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 requirements.
  • Lead and support equipment lifecycle activities, including requalification, decommissioning, and periodic review.
  • Ensure data integrity compliance in computerized systems interfaced with analytical instruments.
  • Collaborate with Quality, Validation, Metrology, IT, and Lab teams to define qualification strategies for new and upgraded equipment.
  • Maintain traceability between user requirements, functional specifications, and qualification deliverables.
  • Provide guidance on change control and impact assessments for equipment modifications or upgrades.
  • Support audits and inspections by presenting qualification documentation and providing SME-level responses.
  • Drive continuous improvement in qualification practices and documentation templates across global sites.
Qualifications:
  • Bachelor's or Master's degree in Chemistry, Engineering, Life Sciences, or a related technical field.
  • Experience in analytical equipment qualification, preferably in a GMP-regulated medical device or pharmaceutical environment.
In-depth understanding of:
  • FDA regulations (21 CFR Parts 820, 210/211, 11)
  • GAMP 5 and ISO 13485
  • Data integrity principles (ALCOA+)
  • Experience qualifying and maintaining Manufacturing equipment.
  • Familiarity with electronic document systems, validation tools, and computerized system validation.
Preferred Qualifications:
  • Certification in Lean Six Sigma, ASQ, or ISPE.
  • Experience supporting global harmonization of validation practices across multi-site environments.
  • Working knowledge of medical device testing requirements, especially for infusion devices, sensors, or diagnostic platforms.
* Ladders Estimates

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