Process Engineer/Transfer - Technical Services

Hikma Pharmaceuticals-posted 3 months ago
Full-time • Entry Level
Columbus, OH
5,001-10,000 employees
Chemical Manufacturing
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As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. We are seeking a talented and motivated Process Engineer/Transfer - Technical Services to join our team. In this role, you will be responsible for transferring products of varying types (Generic commercialization, Site Transfers, Buy-ins, Third Party & key lifecycle (Alt. API) from R&D or applicable partner to Operations, including supporting process development and registration, performing scale-up / validation, site transfer, start-up of commercial production, and transfer to lifecycle support. Minimize obstacles during development, product transfer, validation, and commercialization through utilization of risk-mitigation strategies, best practice sharing, and influence with R&D, Supply Chain, and Operations colleagues.

  • Collaborates with development partners/customers during the process development and registration of new product NDAs, ANDAs, and/or site transfers, ensuring that all project timelines are met.
  • Represent Process Transfer Technical Services and Operations in the development and filing of new products.
  • Collaborate with development partners (e.g. Product Development) during development and pilot scale batch production.
  • Provide critical review of new products/processes regarding fit with operational capabilities.
  • Provide feedback to product development or partners on potential critical mismatches between new products/processes and operational capabilities.
  • Collaborate with product development or partners in the selection and/or design of processes and systems which meet product and regulatory requirements.
  • Create documentation based on process design parameters mutually agreed upon with product development partners.
  • Collaborate with product development or partners to drive shared business ownership and continuous process improvements.
  • Execute assigned project deliverables with moderate guidance from functional management and/or Senior Process Engineers.
  • Coordinate Process Risk Analysis, Scale-up/Transfer trials, and Process Validation of new products.
  • Perform Risk Assessment processes at applicable development gates.
  • Create documentation for scale-up, evaluation, and validation batch production.
  • Develop validation strategies and documentation based on standard approaches modified as necessary.
  • Collaborate with product development and partners during scale-up and validation production.
  • Liaise with lifecycle team to ensure consultation regarding launch projects.
  • Collaborate with peers to identify and prioritize product quality and process robustness optimization opportunities.
  • Provide around-the-clock technical support to production.
  • Participate in and lead functional investigations and participate in cross-functional investigations.
  • Implement and support formulation, process, and specification improvements.
  • Share best practices across the organization.
  • Liaise with Drug Regulatory Affairs (DRA) and Product Development to support documentation.
  • Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines.
  • Prepare evaluation protocols/reports, validation protocols/reports, master formula cards and other documents for assigned products/projects.
  • Review process and/or product documentation to ensure accuracy.
  • Identify trends, risks, and variability within analytical data.
  • Coordinate continuous improvement activities for launched products.
  • Collect and analyze Operations process data.
  • Seek out technical solutions to improve performance.
  • Coordinate Batch Size Optimization activities.
  • Collaborate with Change Management to support process and raw materials changes.
  • Transfer launched products to lifecycle support with Lifecycle.
  • B.S. degree or higher in Chemistry, Engineering, Pharmacy, or related scientific discipline.
  • 6 months+ experience in pharmaceutical production environment (this includes internship and/or co-op).
  • Knowledge and understanding of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including cGMP, DEA, and FDA guidances.
  • Knowledge of pharmaceutical production environment with emphasis on scale-up/optimization and validation.
  • Technical knowledge of pharmaceutical processing equipment.
  • Knowledge of pharmaceutical formulation development.
  • Knowledge of pharmaceutical development, technology transfer, or production principles and practices.
  • Critical Thinking: Ability to apply the PDCA principles (plan, do, check, act).
  • Complex Problem Solving: Working knowledge of experimental methodology and design of experiments.
  • Mechanical and technical aptitude: Demonstrated ability to learn functionality and troubleshooting of pharmaceutical manufacturing equipment.
  • Project Management: Organizational skills and ability to facilitate execution of project milestones.
  • Initiative: Works under direct supervision for strategic decisions with minimal supervision for tactical execution.
  • Teamwork: Ability to be an active participant on teams of moderate to high complexity.
  • 1-3 years of experience in pharmaceutical production environment (this includes internship and/or co-op).
  • Proficient knowledge and understanding of applicable laws and regulations regarding development and manufacturing of pharmaceuticals.
  • Demonstrated knowledge of pharmaceutical production environment with emphasis on scale-up/optimization and validation.
  • Demonstrated technical knowledge of pharmaceutical processing equipment.
  • Knowledge of pharmaceutical formulation development.
  • Annual performance bonus, commission, and share potential.
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.
  • A generous paid time off (PTO) bank starting with 20 days.
  • 3 personal days.
  • 11 company paid holidays.
  • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, and prescription drug coverage.
  • Employee discount program.
  • Wellbeing rewards program.
  • Career advancement and growth opportunities.
  • Tuition reimbursement.
  • Paid maternity and parental leave.
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