GMP Facility Assessment Consultant (P -2026 -141)
About The Position
Pioneer GMP Consulting is seeking a GMP Facility Assessment Consultant to support an OTC and cosmetic manufacturing client in evaluating and strengthening facility readiness for compliant operations. This engagement will focus on assessing facility infrastructure, workflows, operational practices, and environmental suitability to support GMP and cosmetic manufacturing expectations. The ideal candidate brings hands-on experience within regulated manufacturing environments and can translate GMP expectations into practical, achievable recommendations for a growing organization. This role requires a strong understanding of facility operations, compliance risk assessment, and the ability to work collaboratively with both leadership and operational teams. This is a highly visible, onsite consulting engagement focused on helping the client establish a scalable and inspection-ready operational foundation.
Requirements
- 5+ years of experience within GMP-regulated manufacturing environments such as OTC, cosmetic, pharmaceutical, biotech, or dietary supplement operations.
- Willingness to travel extensively.
- Strong understanding of GMP facility requirements and operational compliance expectations.
- Experience assessing or supporting manufacturing facilities, operations, engineering, or compliance initiatives.
- Familiarity with facility workflow concepts including personnel and material segregation.
- Ability to identify operational and compliance risks within manufacturing environments.
- Strong written communication skills with experience developing assessment reports or technical documentation.
- Ability to work independently in a client-facing consulting environment.
- Comfortable performing onsite assessments and interacting with operational teams and leadership.
Nice To Haves
- Experience supporting OTC or cosmetic manufacturing operations.
- Familiarity with cosmetic manufacturing expectations, MoCRA considerations, or ISO 22716 principles.
- Experience supporting facility startups, expansions, or remediation efforts.
- Prior consulting experience within regulated manufacturing environments.
- Experience supporting FDA inspection readiness or compliance improvement initiatives.
Responsibilities
- Conduct a comprehensive onsite GMP facility assessment for an OTC and cosmetic manufacturing operation.
- Evaluate facility layout, personnel flow, material flow, and operational workflows for compliance and efficiency risks.
- Assess manufacturing spaces for suitability related to segregation, storage, cleanliness, and operational control.
- Review facility infrastructure including: HVAC systems and airflow suitability, Temperature and environmental controls, Utility capacity and distribution, Equipment placement and operational fit.
- Evaluate storage, handling, and cleaning practices within production and support areas.
- Identify gaps relative to GMP expectations and cosmetic manufacturing best practices.
- Assess facility readiness against applicable FDA expectations and industry standards.
- Provide practical, prioritized recommendations that align compliance needs with business operations and growth plans.
- Support discussions related to lease considerations, facility constraints, and future operational scalability.
- Develop a clear, concise Facility Assessment Report outlining findings, risks, and recommended next steps.
- Communicate observations and recommendations effectively with client leadership and stakeholders.
Benefits
- Competitive consulting rates commensurate with experience.
- Travel reimbursement and related expenses may apply depending on engagement requirements.
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Education Level
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