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Associate Operator

Hovione

East Windsor, NJOnsitePosted 1 day ago$22.50 - $34.62/hour
Full TimeEntry LevelManufacturing & CMCCDMO
Original posting ↗

Summary

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.

Job description

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.

  • Rigorously, efficiently and professionally, organize and execute all production activities, adhering to all applicable procedures and following instructions received from ascending colleagues.
  • Execute with autonomy the production processes.
  • Ensure all documentation under direct responsibility is correctly completed and maintained.
  • Be an advocate for safe operating and high quality performance, alerting ascending colleagues to any potential risks and suggesting production optimizations or improvements.
  • Develop and accumulate strong production knowledge.
  • Demonstrate professionalism and willingness to help, upon request, in the induction and training of new operators, sharing expertise and practical knowledge.
  • Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
  • Be responsible for the safe and efficient operation of various equipment (which may vary according to the Production Area in which the TM are allocated).
  • Maintain clean and organized facilities.
  • Attend and participate fully in all meetings and training to which the TM is invited.
  • Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes. The TM is expected to previously assess and proactively propose solutions for the identified issues.
  • Ensure that all equipment is checked and calibrated before use.
  • Ensure the correct identification and use of equipment (labels, plates, logbooks etc.).
  • Prepare and supervise sample process (according to the Area in which the TM is allocated).
  • Execute production/HSE tasks correctly in Hovione systems (including but not limited to SAP, LIMS, SchedulePro etc.).
  • Use computer programs correctly (including but not limited to email, SAP, LIMS, SchedulePro and XNET).
  • Troubleshoot systems and take appropriate action as required.
  • Use the Personal Protective Equipment and keep it in good condition.
  • Collaborate in internal and external audits / inspections as requested.
  • Actively collaborate in investigations of abnormal/unexpected events.
  • Follow all annual performance review requirements, including completion of the self-assessment.
  • Suggest and participate in improvements in the area in which the TM is assigned.
  • Collaborate in the revision of any area documents as requested (IOPs, others).
  • Participate, as required, in the induction, training and supporting of new Operators across Hovione.
  • Collaborate in the integration of the transferred Operators from other areas.
  • 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.

We are looking to recruit a Candidate:

  • Full secondary school qualifications or equivalent (mandatory) and vocational qualification (highly desirable)
  • Experience of working in a manufacturing or production environment (mandatory).
  • Formal knowledge or experience of working with process systems utilized in fine chemicals or pharmaceutical operations (mandatory).
  • Successful completion of all mandatory training as an Operator (mandatory).
  • A solid understanding of all Hovione unit operations (mandatory).
  • A very strong understanding of GMP regulations (mandatory).
  • Able to comply with the tasks described in the technical competences matrix applicable to functional Area.
  • Numerical capability for simple arithmetic.
  • Clear and open communication skills (written and verbal).
  • Competent (written and verbal) English (highly desirable).
  • Ability to work in shift patterns.
  • Computer literate.
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

Requirements

  • Full secondary school qualifications or equivalent (mandatory)
  • Vocational qualification (highly desirable)
  • Experience of working in a manufacturing or production environment (mandatory)
  • Formal knowledge or experience of working with process systems utilized in fine chemicals or pharmaceutical operations (mandatory)
  • Successful completion of all mandatory training as an Operator (mandatory)
  • A solid understanding of all Hovione unit operations (mandatory)
  • A very strong understanding of GMP regulations (mandatory)
  • Able to comply with the tasks described in the technical competences matrix applicable to functional Area
  • Numerical capability for simple arithmetic
  • Clear and open communication skills (written and verbal)
  • Competent (written and verbal) English (highly desirable)
  • Ability to work in shift patterns
  • Computer literate

Company overview

Hovione is a leading international Contract Development and Manufacturing Organization (CDMO) with over 60 years of experience in pharmaceutical development and manufacturing operations. Founded in 1959 as a family-owned Portuguese company, Hovione has grown into a global specialist with FDA-inspected manufacturing facilities in the USA, Portugal, Ireland, and China, along with development laboratories in Lisbon and New Jersey. The company provides fully integrated services for drug substances, drug product intermediates, and finished drug products, specializing in complex particle engineering technologies including spray drying for amorphous solid dispersions, continuous tableting, and inhalation drug development. Hovione serves 19 of the world's top 20 pharmaceutical companies and has been involved in 5-10% of drugs approved annually by the FDA. With nearly 2,500 employees worldwide, the company maintains an exceptional regulatory track record with no product recalls or warning letters throughout its history. Hovione was the first chemical/pharmaceutical company to become a Certified B Corp, reflecting its commitment to sustainability and social responsibility.

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