Pharma Validation & Documentation Specialist

Glatt Group

Ramsey (NJ)

Hybrid

USD 68,000 - 83,000

Full time

14 days+

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Job summary

Glatt Air Techniques Inc. in Ramsey, NJ is seeking a Technical Specialist / Validation to generate and oversee technical documents supporting pharmaceutical development, manufacturing, facilities, QA and QC.

You will develop SOPs, CAPAs, OOS and validation protocols for the Pharmaceutical Services Division with emphasis on fluid bed granulation, blending, milling, compression, encapsulation, coating and packaging.

Qualifications

  • BA/BS in biology, chemistry, pharmacy, engineering or related tech field.
  • At least 5 years of development or manufacturing experience in a cGMP solid dosage manufacturing environment.
  • Background in solid dosage, fluid bed processing preferred.
  • Ability to write clear, compliant processing steps and reports.
  • Strong English skills and MS Office proficiency.

Responsibilities

  • Create, manage, and oversee generation of technical documents (SOPs, CAPAs, OOS, IQ/OQ/PQ etc.).
  • Prepare and update SOPs, change requests, and validation reports.
  • Coordinate with departments to develop process, cleaning and validation protocols.
  • Maintain templates and guidelines to ensure cGMP compliance.
  • Support internal audits and validation activities at the site.

Skills

Technical writing
Quality compliance
Detail oriented
Project coordination
English proficiency

Education

BA/BS in biology, chemistry, pharmacy, engineering

Tools

Microsoft Office
CSV

Job description

Glatt Air Techniques Inc. in Ramsey, NJ is seeking a Technical Specialist / Validation to generate and oversee technical documents supporting pharmaceutical development, manufacturing, facilities, QA and QC.

You will develop SOPs, CAPAs, OOS and validation protocols for the Pharmaceutical Services Division with emphasis on fluid bed granulation, blending, milling, compression, encapsulation, coating and packaging.

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