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Hovione

CDMO for complex drug APIs manufacturing

Process Engineer

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeEast Windsor, NJ, USA

About the Job

Requirements

  • A degree in a field of Science or Engineering is required; Chemical Engineering is preferred.
  • Experience working in the pharmaceutical industry in Pharmaceutical Fine Chemistry, Particle Engineering, or Drug Product development, scale-up, or production is mandatory.
  • Training and experience in Good Manufacturing Practices and Health, Safety, and Environment practices are desired.
  • Experience in equipment and technology design is required.
  • Experience in technical manufacturing support is required.
  • Experience in technical transfer and capital project support is required.
  • Experience with multiple projects and products from early-stage development through commercial scale is required.
  • Strong interpersonal skills for effective written and verbal interaction with stakeholders are required.
  • Competent written and verbal English is required.
  • Computer literacy and good working knowledge of Microsoft Office and SAP are required.
  • Intermediate knowledge of organic chemistry and/or particle-engineering technologies is required.
  • Intermediate knowledge of scale-up of chemical-engineering operations and/or drug product is required.
  • The candidate must have the knowledge, experience, and skills to conduct tasks in accordance with established rules and procedures.

Responsibilities

  • Enable efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable current Good Manufacturing Practices and Health, Safety, and Environment regulations and business requirements.
  • Define, implement, and optimize manufacturing processes and systems to adhere to schedules, manage internal people and equipment resources, and meet customer requirements.
  • Promote and follow applicable Good Manufacturing Practices, Health, Safety, and Environment regulations, legislation, company policies, procedures, and industry standards.
  • Plan and design manufacturing processes to produce intermediates and final products according to project plans, reliably, on time, within budget, and in compliance with applicable requirements.
  • Prepare and review manufacturing-process documentation accurately and on time, including batch production records, campaign reports, change controls, operating manuals and procedures, mass-balance sheets, bills of materials, cost proposals, validation plans and reports, and other Good Manufacturing Practices documentation.
  • Conduct risk assessments for assigned activities and projects according to established procedures and policies, ensuring identified hazards are addressed before operational activities.
  • Report, investigate, and document abnormal observations, potential risks, discrepancies, deviations, and non-conformances according to internal procedures.
  • Devise and implement corrective and preventive actions as appropriate.
  • Complete training specified in the training plan.
  • Report abnormal conditions at installations promptly to trigger corrective maintenance.
  • Identify corrective and preventive actions to maintain installations in good condition.
  • Lead multiple process-engineering projects with limited support and liaise directly with customer project teams.
  • Update the Line Manager and team members on relevant occurrences and trends that may significantly affect area key performance indicators.
  • Train operational team members on manufacturing processes, production systems, and procedures.
  • Participate in the induction of new colleagues as required and ensure they are trained according to established training plans.
  • Maintain high production-area standards, including hygiene, housekeeping, and equipment maintenance, and promote safe operations and high-quality performance.
  • Support internal stakeholders by generating 3P’s and answering queries about costs and cycle times associated with assigned processes, where applicable.
  • Assist with audits and investigations.
  • Support generation and reporting of team key performance indicators and complete annual performance-review requirements, including self-assessment.
  • Contribute to designing new facilities and modifying existing facilities.
  • Share technical knowledge with team members in a collaborative work environment.
  • Develop engineering expertise and share state-of-the-art technologies and methodologies within the area.
  • Initiate and prepare technology transfers and process-improvement projects for established and new processes using appropriate available technologies, practices, and tools.
  • Improve productivity by reviewing, proposing, planning, and implementing new technologies, methods, and practices to optimize manufacturing processes.
  • Create and review cost proposals and project plans for optimization projects.
  • Undertake additional tasks commensurate with the role as required.
  • Carry out assigned tasks safely, following instructions and applicable environmental, health, and safety rules, procedures, regulations, and codes of practice.

Desired Qualifications

  • Training and experience in Good Manufacturing Practices and Health, Safety, and Environment practices.

About the Company

Hovione

CDMO for complex drug APIs manufacturing

Hovione is a contract development and manufacturing organization that creates and scales active pharmaceutical ingredients (APIs) for medicines. It handles complex chemistry and specializes in processes like particle engineering and spray drying to improve drug absorption. It differentiates itself through a long history of tackling difficult compounds, deep manufacturing expertise, and an FDA-inspected global footprint across Portugal, Ireland, China, and the US. Its goal is to help drug developers bring new medicines to market efficiently by providing high-quality, scalable manufacturing and expanding capacity, especially in the U.S.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Loures, Portugal
Founded
1959

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