Tech Transfer Engineer

Overview

Transfer and support commercial drug substance manufacturing processes.

Key Responsibilities

• technical transfer
• gmp documentation
• process improvement
• statistical analysis
• inspection readiness
• on‑site support

Tasks

-Work with Internal Partners to deliver technical transfer of our drug substance program -Translate understanding of GMP requirements and current regulations and develop standardised work to meet these requirements by partnering with Operations, Quality, and other Internal Partners. -Responsible for participation in creating, sharing, and adopting best practices and business process strategies. -Provide on-site coverage in support of Technology Transfer Person-In-Plant Activities. -Ensure that External Partners are inspection-ready for all routine inspections and/or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory. -Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings. -Responsible for technical activities for the commercial manufacturing process, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.

Requirements

• statistical analysis
• chemical eng
• documentation
• gmp
• tech transfer
• 3+ years

What You Bring

-Experience with statistical analysis, process performance evaluation, and data management tools. -Degree in Chemical Engineering, Biotechnology, Biochemistry, or a related scientific or engineering discipline. -Proven experience in authoring and reviewing technical documentation, investigations, and validation protocols (IQ/OQ/PQ). -At least 2 years of experience in drug substance manufacturing, technology transfer, or process development. -Strong knowledge of GMP, regulatory compliance, and industry guidelines (e.g., ICH, FDA, EMA). -Minimum of 3 years’ experience in a GMP-regulated biopharmaceutical, biotechnology, or pharmaceutical manufacturing environment.

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About Tandem Project Management Ltd.

-Founded in the heart of Ireland, Tandem Project Management Ltd. has grown into a key player in delivering high-quality project management solutions across multiple industries. -The company has a proven track record of success in managing large-scale, complex projects, consistently delivering on time and within budget. -Specialising in sectors like industrial, commercial, residential, and transport, Tandem brings expertise to projects ranging from urban developments to large infrastructure projects. -Tandem Project Management Ltd. thrives in challenging environments, with a deep understanding of project intricacies and client requirements. -Their approach is rooted in collaboration, working closely with clients and stakeholders to ensure projects meet all expectations and deliver lasting value. -The firm is known for its hands-on, proactive management style, providing solutions at every stage of the project lifecycle. -With a focus on maintaining robust relationships, Tandem is dedicated to fostering trust and long-term partnerships with clients.

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