Job Description
Client: Leading Pharmaceutical Company
Location: Multiple Sites (with 50% travel)
Role Overview
We are seeking highly experienced Subject Matter Experts (SMEs) across key manufacturing domains: Compression Operations. Each SME will be responsible for providing deep technical expertise, process optimization, and compliance oversight in their respective area. The role requires extensive travel (~50%) to support multiple facilities, audits, and technology transfers.
Key Responsibilities (per area)
SME – Compression
- Lead process design, scale-up, and troubleshooting for tablet compression.
- Provide expertise on different makes/models of compression equipment, including OEM systems.
- Develop SOPs, batch records, and validation protocols.
- Train operators and ensure compliance with cGMP and regulatory standards.
Common Responsibilities
- Travel (~50%) to our facilities for audits, training, troubleshooting, and technology transfer.
- Collaborate with R&D, QA, and manufacturing teams to ensure process excellence.
- Author and review technical documentation, validation protocols, and reports.
- Ensure compliance with global regulatory standards (FDA, EMA, WHO).
- Mentor and train operators and technical staff.
Qualifications
- Bachelor’s/Master’s in Pharmacy, Biotechnology, Chemical/Mechanical Engineering, or related discipline.
- 8–12 years of hands-on experience in the respective domain (Compression, Granulation, ).
- Proven expertise working with different makes/models of equipment or directly with OEMs.
- Strong knowledge of cGMP, regulatory requirements, and validation practices.
- Excellent communication, analytical, and cross-functional collaboration skills.
- Willingness to travel up to 50% of the time.
. Skillset Required: Engineering, Projects, Compression, Granulation
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