Senior Process Engineer

Biopharma Careers; Inverin; On-site; EUR 70,000 - 95,000; Full time

Job summary

Viatris seeks a Senior Process Engineer in Manufacturing Science and Technology to drive process improvements and technology transfers. You will work across cross-functional teams to design experiments using quality by design principles, investigate deviations, and support new product introductions.

The role requires a science degree with pharma experience, sterile facility exposure, and strong technical writing skills.

Qualifications

• Degree in a science discipline with at least 3 years pharmaceutical experience.
• Sterile facility experience.
• Proven experience in Process Performance Qualification.
• Experience in investigation and CAPA implementation.
• Knowledge of aseptic filling machines (preferred).

Responsibilities

• Lead technology transfer and process validation activities.
• Plan and execute Process Performance Qualification batches.
• Support product lifecycle projects and transfers.
• Assist investigations and CAPA implementations with data-driven analyses.
• Provide technical support for new product introduction and changes.

Skills

Process Engineering

Data Analysis

Quality by Design

Technical Writing

Team Collaboration

Education

Bachelor's degree in science

Tools

CAPA systems

Job description

Mylan Teoranta

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here’s how the Senior Process Engineert role in Manufacturing Science and Technology will make an impact:

• Employing sound technical expertise to support manufacturing
• Supporting change management through technical risk assessment and running technical studies as required
• Capability to design experiments by employing quality by design principles to run scientific protocols to investigate deviations in manufacturing
• Strong scientific focus with a curious mind to identify improvement opportunities to reduce product variability overall
• Strong ability to analyse technical data from multiple sources in a methodical manner
• Strong technical writing capability to write high quality scientific protocols and reports including critical review of data to form sound scientific recommendations and conclusions
• A track record of developing innovative and creative solutions to complex and challenging problems working across different functional teams both internally and externally
• Key participant in manufacturing quality investigations supporting through product impact assessments and running technical studies as required
• Providing technical support to new product introduction, product transfers and alternate source qualifications.
• Support continuous process verification and working with impacted functions to address any trends observed

Key responsibilities for this role include:

• Assume responsibility for technology transfer projects introduced into the facility
• Plan, co-ordinate and execute exhibit and Process Performance Qualification batches as part of business requirements.
• Planning and executing product lifecycle projects including alternative API source qualification, processing hold times extensions and batch upscale.
• Preparation of cleaning validation documentation as required (protocols, reports and annual reviews).
• Co-ordinate and support manufacturing investigations.

A motivated and flexible self-starter operating with minimum supervision and managing tasks through to completion as well as coaching team members.

Excellent communication skills with ability to exchange ideas and information effectively in a concise and logical way.

Demonstrated strong team-working skills including ability to work and influence effectively across functions on and off site

Continuous improvement mindset with a Positive, can-do attitude.

The minimum qualifications for this role are:

• A degree in a science discipline with at least 3 years pharmaceutical experience (industry).
• Sterile facility experience.
• Proven experience in Process Performance Qualification.
• Experience in investigation and CAPA implementation.

Preferred Qualifications

• Experience with aseptic filling machines
• Experience with pharmaceutical compounding
• Knowledge of single use systems a bonus

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. Viatris is an Equal Opportunity Employer.

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.