Process Engineer

This is a 2nd shift position - 1:30pm - 10:00pm

Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.

• Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hoviones 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.

• 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)
• Training and experience in GMP and HSE practices (desired)
• 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.

In compliance with the New Jersey Pay Transparency Act, Hovione discloses a base pay range for this U.S. based position. Actual pay is influenced by location, skills, experience, and qualifications. Non-exempt employees are eligible for overtime, and all roles may include a short-term incentive bonus. Employment is at-will, and compensation may change based on performance or market conditions. Benefits include 401(k), paid time off, leaves, and health coverage (medical, dental, vision), subject to plan terms. Full benefit details are shared upon offer.

Process Engineer Compensation Range: $92,040- $147,264

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. We are committed to creating an inclusive recruitment experience and welcome applications from all qualified candidates. If you require any reasonable accommodation or support during the application or interview process, please contact us, and we will be happy to assist.

Notice to Agencies and Search Firms Representatives

Hovione does not accept unsolicited resumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral.