About Hovione
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, technology, and manufacturing 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:This role serves as Hovione's global technical authority for microbiology and contamination control, ensuring that regulatory intelligence, scientific expertise, and industry best practices are translated into robust standards, harmonized procedures, and effective support for sites, development activities, and quality functions across the network. The position is focused on enterprise-wide technical leadership, process ownership, and strategic influence, with responsibility for shaping microbiological quality standards and contamination control practices, guiding risk-based decision-making, and driving consistency across Hovione's small molecule and biotechnology operations. Act as Hovione's Subject Matter Expert (SME) and Global Process Owner for:- Microbiological Quality Systems
- Contamination Control Strategy (CCS) for aseptic and non-aseptic manufacturing operations
- Sterility Assurance and Aseptic Processing
- Environmental Monitoring Programs
- Cleanroom Classification, Qualification and Operation
- Cleaning, Disinfection and Microbiological Control Programs
- Microbiological Risk Assessment and Risk-Based Decision Making
- Regulatory Intelligence and Industry Best Practices related to microbiology and contamination control
- Microbiological aspects of Product Development, Technology Transfer, New Product Introduction & Process Validation
- Microbiological considerations associated with both small molecule and biotechnology manufacturing operations
- Acting as the company's global technical authority for microbiology and contamination control matters.
- Leading the development, maintenance, and continuous improvement of global policies, standards, and procedures related to microbiology, contamination control, and sterility assurance.
- Monitoring evolving regulatory requirements, industry guidance, and health authority expectations, ensuring timely incorporation into Hovione's Quality System.
- Driving harmonization and standardization of microbiological and contamination control practices across all Hovione sites.
- Providing expert support to Manufacturing, Quality, Engineering, Technical Services, and R&D teams on microbiological and contamination control matters.
- Supporting investigations, risk assessments, deviations, CAPAs, and change controls involving microbiological contamination risks.
- Supporting customer audits and regulatory inspections as the company's SME in microbiology and contamination control.
- Identifying, assessing, and deploying industry best practices to ensure a science- and risk-based approach across the organization.
- Delivering training, coaching, and technical guidance to strengthen microbiological and contamination control capabilities throughout the organization.
- Leading global initiatives and cross-functional projects with significant impact on product quality, compliance, patient safety, and operational excellence.
- Facilitating effective communication and collaboration across sites to identify opportunities for continuous improvement and consistent implementation of standards.
- Degree in Microbiology, Pharmacy, Biological Sciences, Biotechnology, Life Sciences, or a related scientific discipline.
- Advanced knowledge of microbiology applied to pharmaceutical manufacturing environments.
- Strong knowledge of global GMP requirements, including EU GMP Annex 1, FDA, PIC/S, ICH, and other applicable regulatory requirements and guidance.
- Fluency in English.
- Strong technical writing, communication, and influencing skills.
- Computer literate with good working knowledge of the Microsoft Office suite.
- Minimum 10 years of experience within the pharmaceutical industry and/or CDMO environment.
- Extensive experience in microbiology, contamination control, sterility assurance, and GMP-regulated manufacturing environments.
- Demonstrated experience supporting both aseptic and non-aseptic manufacturing operations.
- Significant experience supporting small molecule and biotechnology products, including development, scale-up, technology transfer, and commercial manufacturing activities.
- Strong understanding of the microbiological, contamination control, and regulatory challenges associated with both chemical and biological manufacturing processes.
- Experience with environmental monitoring, cleanroom operations, microbial contamination investigations, utilities microbiological control, and cleaning and disinfection programs.
- Experience supporting regulatory inspections, customer audits, and health authority interactions.
- Demonstrated ability to influence stakeholders and drive alignment across multiple functions, disciplines, and geographical locations without direct authority.
- Experience leading complex global initiatives and driving harmonization of standards, procedures, and best practices across multiple sites.
- Strong risk-management, problem-solving, and decision-making capabilities.
- Knowledge of industrial safety principles and the application of Risk Management and Lean Six Sigma methodologies in GMP environments.
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.
Skills Required
- Degree in Microbiology, Pharmacy, Biological Sciences, Biotechnology, Life Sciences, or a related scientific discipline
- Advanced knowledge of microbiology applied to pharmaceutical manufacturing environments
- Strong knowledge of global GMP requirements, including EU GMP Annex 1, FDA, PIC/S, ICH, and applicable regulatory guidance
- Fluency in English
- Strong technical writing, communication, and influencing skills
- Computer literacy and working knowledge of Microsoft Office
- At least 10 years of experience in the pharmaceutical industry and/or CDMO environment
- Extensive experience in microbiology, contamination control, sterility assurance, and GMP-regulated manufacturing
- Experience supporting aseptic and non-aseptic manufacturing operations
- Experience supporting small molecule and biotechnology products, including development, scale-up, technology transfer, and commercial manufacturing
- Experience with environmental monitoring, cleanroom operations, microbial contamination investigations, utilities microbiological control, and cleaning and disinfection programs
- Experience supporting regulatory inspections, customer audits, and health authority interactions
- Experience influencing stakeholders and driving alignment across multiple functions and geographical locations without direct authority
- Experience leading complex global initiatives and harmonizing standards, procedures, and best practices across multiple sites
- Strong risk-management, problem-solving, and decision-making capabilities
- Knowledge of industrial safety principles and Risk Management and Lean Six Sigma methodologies in GMP environments
What We Do
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.
