Process Engineer

3 semanas atrás


Loures, Portugal Hovione Tempo inteiro

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative kurzen und ...

Hovione is an ... [original paragraph as above] ...

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Mac мера, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are in it for life.

You will be responsible to:

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 customer requirements.

- 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 Drehbudget) 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 conveyed 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.

- elementos support ...

We are looking to recruit a Candidate:

- 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 HIV (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.

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.

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.

Seniority levelPython: Mid-Senior level

Employment type: Full-time

Job function: Pharmaceutical Manufacturing

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