Process Engineer

Hovione•East Windsor, NJ

8d•$92,040 - $147,264•Onsite

About The Position

Hovione is an international Contract Development and Manufacturing Organization (CDMO) that supports the development and manufacture of drug substances, intermediates, and drug products. They are globally recognized for their leadership in specialized technologies like Spray Drying and Continuous Tableting. Hovione emphasizes a purpose-driven, caring, collaborative approach and is committed to an inclusive environment where diverse team members can contribute to innovation and quality. The company offers opportunities for professional development and career growth. This role is responsible for enabling the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with cGMP and HSE regulations. The Process Engineer will define, implement, and optimize manufacturing processes and systems to meet schedules, manage resources, and fulfill customer requirements. They will also play a key role in project management, technical support, and continuous improvement initiatives.

Requirements

Degree in a field of Science or Engineering (with preference in Chemical Engineering)
Experience working within the pharmaceutical industry in Pharmaceutical Fine Chemistry and/or Particle Engineering and/or or Drug Product (areas of development, scale-up and production) (mandatory)
Experience in equipment and technology design
Experience in technical manufacturing support
Experience of technical transfer and capital project support
Experience of multiple projects and products from early stage development to commercial scale
Strong interpersonal skills to enable effective interactions with stakeholders (written and verbal)
Competent (written and verbal) English
Computer literate with good working knowledge of the MS Office package and SAP
Intermediate knowledge in organic chemistry and/or particle engineering technologies
Intermediate knowledge in scale-up of chemical engineering operations and/or drug product
Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

Nice To Haves

Training and experience in GMP and HSE practices (desired)

Responsibilities

Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities.
Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures.
Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, cost proposals, validation plans and validation reports and other GMP related documentation for all processes run in operations.
Execute and ensure, with autonomy, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities.
Report, investigate and document any abnormal observations, potential risks, discrepancies, deviations and non-conformances in accordance with Hovione internal procedures.
Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate.
Participate in all necessary training as defined in the training plan.
Report abnormal situations at the installations, as soon as these are detected so that corrective maintenance is triggered in due time.
Identify the necessary corrective and preventive actions to keep, in a proactive manner, the installation in good conditions.
Act as the lead process engineer in multiple projects with limited support and liaises directly with customer project teams.
Updates the Line Manager and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs.
Provide training on manufacturing processes, production systems and procedures to operational team members
Participate, as required, in the induction of new colleagues ensuring they are appropriately trained in accordance with established training plans.
Drive high standards in the production area (e.g. good hygiene, housekeeping and equipment maintenance practices), and act as an advocate for safe operating and high quality performance.
Support internal stakeholders on, including but not limited to, generation of 3P’s and answering queries on cost and cycle time associated with assigned processes (where applicable)
Assist with audits and investigations.
Support the generation / reporting of KPIs for the team and follow all annual performance review requirements, including completion of the self-assessment.
Contribute to the design of new facilities or to the modification of existing ones.
Engage in a supportive work environment that allows for open collaboration between team members to share technical knowledge.
Develop and accumulate strong engineering expertise, sharing knowledge of state-of-the-art technologies and methodologies within the area.
Initiate and prepare tech-transfers and process improvement projects for established and new processes utilizing best available technology, practices and tools.
Contributes to the increase of productivity by reviewing, proposing, planning and implementing the introduction of new technologies, methods and practices that have the opportunity to optimize the manufacturing processes.
Responsible for creating and reviewing cost proposals and project plans when implementing optimization projects.
Undertake any additional tasks commensurate with the role as and when required
Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.