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Recruitment Specialist @ Arcadis DPS Group
Tech Transfer Engineer – Drug Product (NPI & Lifecycle Management)
Shift Pattern: 2 days (7am–7pm), 2 nights (7pm–7am), followed by 4 days off
Shift Premium: 35% shift rate
Reporting To: Senior Process Development Engineer
Overview
Our client is seeking a highly capable and proactive Tech Transfer Engineer to support new product introductions (NPI) and lifecycle management (LCM) activities at a leading biopharmaceutical manufacturing facility. This role is central to leading Process Performance Qualification (PPQ) and providing high-level technical support for biologics drug product manufacturing, as part of a global process development and tech transfer organization.
The successful candidate will take ownership of drug product technology transfers into GMP manufacturing suites, act as the process subject matter expert post-transfer, and support cross-functional collaboration for efficient, compliant product launches.
Key Responsibilities
* Lead NPI projects into designated manufacturing suites; act as Process Development SME post-transfer.
* Manage full product transfer lifecycle including engineering studies, line characterization, PPQ, and preparation for regulatory submission.
* Troubleshoot technical issues involving drug substance freezing/thawing, formulation, sterile filling (vials, syringes, devices), lyophilisation, and product inspection/transport.
* Deliver technical support in process characterization, sterile processing, technology transfer, and validation.
* Contribute to resolution of Change Controls, non-conformances (NCs), and CAPAs.
* Develop and approve validation protocols for filling operations (vials/syringes).
* Ensure all validation activities meet safety, GMP, training, and documentation standards.
* Participate in cross-functional validation teams to support project milestones.
* Interface with global and local teams, including quality, engineering, validation, and operations.
* Support development of validation programs and internal guidelines.
* Contribute to deviation investigations, filter and shipping validation reporting.
* Assist with process flow documentation and product quality assessments.
Basic Qualifications
* Bachelor’s degree in Science, Engineering, or related discipline with 5+ years of relevant experience, OR
* Master’s degree with 3+ years of experience, OR
* Associate’s degree with 10+ years of directly related experience.
* Knowledge of cGMP standards and global regulatory requirements.
* Excellent problem-solving, documentation, and communication skills.
Preferred Qualifications
* Master’s or PhD in a science or engineering field.
* 5+ years in commercial protein drug product environments with a focus on sterile processing, validation, or tech transfer.
* Technical understanding of freeze-thaw, filtration, mixing, filling (PpK/batch homogeneity), and lyophilisation.
* Knowledge of protein biochemistry and stability.
* Strong project management skills; ability to manage multiple projects and priorities.
* Familiarity with quality systems and global tech transfer strategy.
* Experience leading cross-functional and global teams.
Additional Information
* The role requires participation in 24/7 operational support once or twice per quarter, lasting approximately 1–2 weeks.
* A 35% shift premium applies due to the rotating shift schedule.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Product Management and Engineering
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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