Senior Technical Services Manager page is loaded
Senior Technical Services Manager
Postuler locations Inverin, County Galway, Ireland time type Temps plein posted on Offre publiée hier job requisition id R5658984 Mylan Teoranta
Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs:
* Accès: En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.
* Leadership: En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.
* Partenariat: En valorisant notre expertise collective afin de donner accès à tous à nos produits et 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 for 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 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 identifying and implementing 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 with 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 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 generating cGMP documentation (protocols, reports, change controls).
* Practical experience with filling machines, isolators, autoclaves, depyrogenation tunnels, and lyophilizers, modes of operation, CPPs, etc.
* Good knowledge of aseptic behaviors, filter integrity testing, single-use systems, etc.
* Proficiency in data analysis tools (e.g., Minitab) and process modeling software.
* Fundamentals of microbiology and knowledge of unit operations to ensure sterility assurance.
At Viatris, we are dedicated to building a diverse, inclusive, and authentic workplace. If your experience doesn’t fully match every requirement but you’re excited about this role, we encourage you to apply. You might be the right candidate for this or other roles.
Benefits at Viatris
o Competitive salaries, benefits, and an inclusive environment.
o Opportunities for career progression
o Work-life balance initiatives
o Bonus scheme
o Health insurance
o Pension
Diversity & Inclusion at Viatris
We value diversity and inclusion as essential to our mission. Learn more at https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
We are committed to responsible and sustainable operations and empowering people to live healthier lives. More info at https://www.viatris.com/en/about-us/corporate-responsibility
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