Cleaning and Process Validation Engineer

at  Viatris

DPT Laboratories, Ltd.
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.

Every day, we rise to the challenge to make a difference and here’s how the Cleaning and Process Validation Engineer role will make an impact:

Key responsibilities for this role include:

• Provide validation expertise and leadership including, coordinate and achieve project deliverables to meet customer needs, write and review protocols, coordinate, and perform protocol execution (collect field samples, tabulate and statistically analyze results, summarize deviations, as well as troubleshoot failures/problems). Coordinate, track, and report on validation status throughout project lifecycle.
• Develop and defend scientific protocol rationale for study design, sampling requirement, and acceptance criteria using industry accepted standards.
• Generate final reports, compile historical data packages, and route documents for approval.
• Assess impact of proposed changes to validated processes/products.
• Support execution of commercial investigations/deviations as well as their associated CAPAs.
• Support internal and external audits.
• Work within cross-functional teams to determine critical process parameters to quality attributes and/or parameters for products/processes.
• Solve a wide range of challenging validation issues that impact multiple functions following cGMPs and DPT/Viatris standards.
• Establish and maintain cross functional relationships with manufacturing, engineering, quality control, research & development and regulatory affairs for validation optimization and support of a successful validation program.
• Define necessary resources and appropriate timing to deliver required validation project support.
• Develop, implement, and enforce validation procedures and policies.
• Maintain compliance with current applicable regulatory requirements and guidances,i.e., 21 CFR 210-211, EudraLex Annex 15, and any other applicable domestic and international regulations.
• Serve as a technical subject matter expert (SME) and back up to the Validations supervisor/manager in support of department functions. Mentor junior personnel on validation processes and practices.
• Manage competing priorities/projects and maintain tight timelines.
• Develop and maintain relationships with internal and external customers.
• Within area of responsibility, understand and comply with all DPT safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
• Perform other duties as assigned.

The minimum qualifications for this role are:

• Bachelor’s degree (i.e. chemistry, biology, microbiology, engineering) from a four-year college or university is required.
• Minimum 2 years of process and cleaning validation experience within the pharmaceutical industry is required.
• A wide range of validation experience in performing process, packaging, and cleaning validation in a leadership role within pharmaceutical environment. This includes generation of documents as well as execution.
• Excellent communication skills and the ability to interact with cross-functional groups at all levels are required.
• Solid experience validating product/packaging/cleaning processes, or any combination thereof is a must.
• Experience in liquid and/or semi-solid drug manufacturing is a plus.

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. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Key responsibilities for this role include:

• Provide validation expertise and leadership including, coordinate and achieve project deliverables to meet customer needs, write and review protocols, coordinate, and perform protocol execution (collect field samples, tabulate and statistically analyze results, summarize deviations, as well as troubleshoot failures/problems). Coordinate, track, and report on validation status throughout project lifecycle.
• Develop and defend scientific protocol rationale for study design, sampling requirement, and acceptance criteria using industry accepted standards.
• Generate final reports, compile historical data packages, and route documents for approval.
• Assess impact of proposed changes to validated processes/products.
• Support execution of commercial investigations/deviations as well as their associated CAPAs.
• Support internal and external audits.
• Work within cross-functional teams to determine critical process parameters to quality attributes and/or parameters for products/processes.
• Solve a wide range of challenging validation issues that impact multiple functions following cGMPs and DPT/Viatris standards.
• Establish and maintain cross functional relationships with manufacturing, engineering, quality control, research & development and regulatory affairs for validation optimization and support of a successful validation program.
• Define necessary resources and appropriate timing to deliver required validation project support.
• Develop, implement, and enforce validation procedures and policies.
• Maintain compliance with current applicable regulatory requirements and guidances,i.e., 21 CFR 210-211, EudraLex Annex 15, and any other applicable domestic and international regulations.
• Serve as a technical subject matter expert (SME) and back up to the Validations supervisor/manager in support of department functions. Mentor junior personnel on validation processes and practices.
• Manage competing priorities/projects and maintain tight timelines.
• Develop and maintain relationships with internal and external customers.
• Within area of responsibility, understand and comply with all DPT safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
• Perform other duties as assigned

The minimum qualifications for this role are:

• Bachelor’s degree (i.e. chemistry, biology, microbiology, engineering) from a four-year college or university is required.
• Minimum 2 years of process and cleaning validation experience within the pharmaceutical industry is required.
• A wide range of validation experience in performing process, packaging, and cleaning validation in a leadership role within pharmaceutical environment. This includes generation of documents as well as execution.
• Excellent communication skills and the ability to interact with cross-functional groups at all levels are required.
• Solid experience validating product/packaging/cleaning processes, or any combination thereof is a must.
• Experience in liquid and/or semi-solid drug manufacturing is a plus