Hovione

CQV Engineer

Hovione  •  Loures, PT (Onsite)  •  20 days ago
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Job Description

Join a Market Leader

At Hovione, we help partners turn scientific innovation into medicines that reach patients around the world. For more than 65 years, we have connected science and technology to scale complex ideas into high-quality and innovative solutions that truly make a difference.

As an international Contract Development and Manufacturing Organization (CDMO), we support the development and manufacture of drug substances, intermediates and drug products across the full life cycle. We are globally recognized for our leadership in specialized technologies such as Spray Drying and Continuous Tableting. But what truly sets us apart is not just what we do — it is how we do it: with purpose, care, collaboration and a deep commitment to doing the right things right.

Our people are the reason for our success. We are a global and diverse team of more than 2,600 team members across Europe, the USA and Asia, bringing together different experiences and perspectives to help our partners to overcome complex challenges. We believe that an inclusive environment — where everyone, regardless of background, identity or ability, is respected, heard and empowered to contribute — is essential to drive innovation, ensure quality, and secure long‑term sustainable success.

And as we grow, so do the opportunities for our people to develop, broaden their perspectives and build meaningful careers. Because at Hovione, better starts with those who choose to make a difference every day. Will you be one of them?

You will be responsible to:

  • Lead Commissioning, Qualification and Validation (CQV) activities for facilities, equipment, utilities, and systems in compliance with GMP and regulatory requirements.
  • Develop and execute CQV strategies, including DQ, IQ, OQ, and PQ, ensuring validation readiness and successful project delivery.
  • Plan and manage commissioning activities, including FAT and SAT, coordinating cross-functional dependencies and project timelines.
  • Lead qualification of critical GMP utilities such as HVAC, purified water, compressed air, and related systems.
  • Assess new or modified systems within change control processes to define qualification strategies and documentation scope.
  • Execute commissioning and IQ protocols, ensuring systems are compliant, functional, and operationally ready.
  • Coordinate and manage external vendors for testing, execution, and analytical activities.
  • Manage technical deviations, perform root cause investigations, and lead the implementation of CAPAs.
  • Ensure accurate registration of equipment and instruments in SAP, aligned with maintenance and calibration plans.
  • Support audits and inspections by ensuring documentation readiness and compliance with GMP, FDA, and ICH guidelines.

We are looking to recruit a Candidate:

  • University degree, or equivalent qualification in Engineering or similar scientific field;
  • Relevant experience in installation management or equipment qualification and automation preferably with a focus in chemical plants or Pharmaceutical industry;
  • Training and experience of GMP and HSE practices;
  • Relevant understanding and knowledge of legislation applicable to engineering projects and quality requirements applicable to technical installations;
  • Competent (written and verbal) English;
  • Computer literate with good working knowledge of the MS Office package;
  • 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. 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 RepresentativesHovione does not accept unsolicited résumes 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. Thank you for your understanding.

Hovione

About Hovione

Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
East Windsor, NJ
Year Founded
1959
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