Process Engineer/Transfer Specialist

4 weeks ago

Columbus, Ohio, United States Hikma Pharmaceuticals PLC Full time
Job Title: Process Engineer/Transfer

Job Summary:

We are seeking a highly skilled Process Engineer/Transfer to join our Technical Services team. The successful candidate will be responsible for transferring products of varying types from R&D or applicable partners to Operations, including supporting process development and registration, performing scale-up/validation, site transfer, start-up of commercial production, and transfer to lifecycle support.

Key Responsibilities:
  • Collaborate with development partners/customers during process development and registration of new product NDAs, ANDAs, and/or site transfers, ensuring all project timelines are met.
  • Represent Process Transfer Technical Services and Operations in the development and filing of new products.
  • Collaborate with development partners during development and pilot scale batch production.
  • Provide critical review of new products/processes regarding fit with operational capabilities.
  • 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.
  • Collaborate with development partners and Operations partners to mitigate risks as identified in Risk Assessment.
  • Develop validation strategies and documentation based on standard approaches and critical process reviews.
  • Write validation reports that document technical product knowledge.
  • Prepare Manufacturing Documentation for submission per Corporate Guidelines.
  • Ensure attention to detail to documentation to ensure quality and timeliness of documents.
  • Share best practices across the organization.
  • Perform peer review of documentation to drive right-first-time performance of department and to ensure accuracy of Technical Services documentation.
  • Review process and/or product documentation to ensure accuracy and to avoid generation of potential NOIs/EAs.
  • Identify differences between processes outlined in Master Manufacturing Formulae and General Conventions.
  • Review data and documentation to ensure accuracy against source data.
  • Identify trends, risks, and variability within analytical data.
  • Share best practices across the organization.
  • Coordinate continuous improvement activities for launched products.
  • Identify product quality and process robustness optimization opportunities.
  • Participate in and lead functional investigations and participate in cross-functional investigations.
  • 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.
  • Collaborate with Drug Regulatory Affairs (DRA) to support assessment of the regulatory impact of potential process changes.
Requirements:
  • B.S. degree or higher in Chemistry, Engineering, Pharmacy, or related scientific discipline.
  • 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 to support pharmaceutical development/process transfer/validation.
  • Mechanical and technical aptitude: Demonstrated ability to learn functionality and troubleshooting of pharmaceutical manufacturing equipment, and understanding of the impact of critical equipment parameters on key product performance parameters at the expert level.
  • Project Management: Organizational skills and ability to facilitate execution of project milestones through the use of project management skills.
  • Initiative: Works under direct supervision for strategic decisions with minimal supervision for tactical execution of tasks of moderate complexity.
  • Teamwork: Ability to be an active participant on teams of moderate to high complexity, and to lead/facilitate teams on tasks of moderate complexity.
  • Training: Skills to effectively educate colleagues on technical principles, process fundamentals, etc.
Preferred Qualifications:
  • 1-3 years of experience in pharmaceutical production environment.
  • Proficient knowledge and understanding of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including cGMP, DEA, and FDA guidances.
  • 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.
What We Offer:
  • 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. Hikma will match 100% of the first 6% of eligible pay that you contribute.
  • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries.
  • 3 personal days (prorated based on hire date).
  • 11 company paid holidays.
  • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits.
  • Employee discount program.
  • Wellbeing rewards program.
  • Safety and Quality is a top organizational priority.
  • Career advancement and growth opportunities.
  • Tuition reimbursement.
  • Paid maternity and parental leave.

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