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ProPharma Group

ProPharma Group

61 jobs near Columbus, OH

Katalyst

Process Validation Engineer

New Haven, CT

We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology ...

Katalyst

Process Validation Engineer

Newark, NJ ยท On-site

* We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology ...

Katalyst

Process Validation Engineer

Enola, PA ยท On-site

* We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology ...

INCOG

Process Validation Engineer

Fishers, IN ยท On-site

TSMS - Process Validation Engineer The Technical Services and Manufacturing Sciences (TSMS) Process Validation Engineer will be responsible for supporting all facets of Process Validation, GMP Floor ...

Valspec

Process Validation Engineer

Raleigh, NC

Process Engineer (Process Validation / PPQ Readiness) Location: Sanford, NC (Onsite) Type: Contract | Full-Time (40 Hours/Week) Duration: Approximately 9 Months Position Summary Our client is seeking ...

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Process Validation Engineer

Katalyst

Indianapolis, IN

Full-time

Re-posted 5 days ago

Job description

Job Description:
We are seeking a Process Validation Engineer to support validation and qualification activities in a GMP-regulated manufacturing environment. The ideal candidate will have experience with process validation, equipment qualification, CSV, temperature mapping, and regulatory compliance.
Responsibilities:
  • Execute process validation and equipment qualification activities (IQ, OQ, PQ, PPQ).
  • Develop, review, and maintain validation protocols and reports.
  • Support Computer Systems Validation (CSV) activities.
  • Perform temperature mapping studies and analyze validation data.
  • Utilize Kneat or similar electronic validation management systems.
  • Support commissioning, qualification, and validation (CQV) projects.
  • Investigate deviations and support CAPA and change control activities.
  • Ensure compliance with GMP, FDA, and regulatory requirements.
  • Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams.
Requirements:
  • Bachelor's degree in Engineering, Science, or a related field.
  • Experience in process validation, equipment qualification, or validation engineering.
  • Knowledge of IQ/OQ/PQ and validation lifecycle activities.
  • Familiarity with CSV principles and regulatory requirements.
  • Experience with Kneat, Ellab, or similar validation tools is preferred.
  • Understanding of GMP/cGMP regulations.
  • Strong documentation, communication, and problem-solving skills.
Preferred Skills:
  • Process Validation.
  • Equipment Qualification.
  • CSV (Computer Systems Validation).
  • Temperature Mapping.
  • Kneat.
  • Ellab Systems.
  • GMP/cGMP Compliance.
  • CAPA and Change Control.

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