Senior Technical Services Manager page is loaded
Senior Technical Services Manager
Apply locations Inverin, County Galway, Ireland time type Full time posted on Posted Yesterday job requisition id R5658984 Mylan Teoranta
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Job Description & Qualifications
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
As part of the Technical Services function the Technical Services Manager – Product/Process will be responsible for coordinating and supporting the development & optimization of aseptic pharmaceutical manufacturing processes, ensuring compliance with regulatory standards, and driving continuous improvement initiatives as well as technical transfer and New Product Introductions. This role involves collaboratively providing input with cross-functional teams, including Production, Product Development, Quality, Regulatory and Engineering, to enhance efficiency, scale-up processes, perform NPIs and troubleshoot manufacturing challenges.
Every day, we rise to the challenge to make a difference and here’s how the Senior Technical Services Manager role will make an impact:
Process Development & Optimization:
* Oversee the design, development, and optimization of aseptic/sterile pharmaceutical manufacturing processes, ensuring robust, scalable, and cost-effective production.
* Initiate and track the execution of process risk assessments (e.g., FMEA) and implement risk-mitigation strategies.
* Drive resolution for investigations into deviations, non-conformances, and root cause analyses.
* Lead technical aspects of scale-up, tech transfer, and commercialization of new products.
Validation & Compliance:
* Oversee the preparation and execution of Process Validation (PV) protocols (e.g., PPQ) and Continued Process Verification (CPV).
* Provide direction and expertise in the generation of change controls aligned with site procedures to support product/process changes
* Provide SME support regulatory filings (e.g., CMC sections of regulatory filings) with process data and technical justifications.
Manufacturing Support & Troubleshooting:
* Manage on-the-floor technical support for routine manufacturing operations, deviations, and process issues.
* Analyze process data trends to drive continuous improvement and reduce variability in critical quality attributes (CQAs).
NPI, Technical Transfer & Scale-Up:
* Guide and manage the technical requirements supporting technology transfers between development, pilot, and commercial-scale manufacturing.
* Collaborate with R&D, and Site Operations teams to ensure smooth process transitions.
* Provide SME level guidance regarding the definition of critical process parameters (CPPs) and critical quality attributes (CQAs) for robust transfer and/or scale-up.
Continuous Improvement & Innovation:
* Support team members in the identification and implementation of process improvements using Lean, Six Sigma, and other problem-solving methodologies.
* Evaluate and introduce new technologies to enhance efficiency, reduce waste, and improve yield.
* Support cost-reduction initiatives while maintaining quality and compliance.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
* Education: Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
* Experience: 5 - 8 years of experience in pharmaceutical manufacturing, process engineering, or technical services. Experience in sterile injectables or biologics manufacturing.
* Strong knowledge of aseptic processing, terminal sterilization, and lyophilization.
* Experience with process validation (PPQ), DOE, and statistical process control (SPC).
* Proficiency in cGMP, Annex 1, FDA, EMA, and ICH guidelines for sterile products.
* Proficient in the generation of cGMP documentation e.g. protocols, report, change control etc.
* Practical experience with filling machines, isolators, autoclaves, depyrogenation tunnels, and lyophilizers, modes of operation, critical process parameters etc.
* Good knowledge of aseptic behaviours, filter integrity testing, single use systems etc.
* Proficiency in data analysis tools (e.g., Minitab) and process modeling software.
* Microbiological fundamentals and knowledge of unit operations to secure sterility assurance.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:
* Excellent career progression opportunities
* Work-life balance initiatives
* Bonus scheme
* Health insurance
* Pension
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility
A t Viatris, we offer competitive salar ies, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance.
We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.
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