Engineer Lead, Equipment Commissioning, Qualification, and Validation, Engineering 1st shift

Company Name: Viatris

Found Description

Mylan Technologies, Inc.

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;
• 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 Engineer Lead, Equipment Commissioning, Qualification, and Validation, Engineering 1st shift role will make an impact:

Key Responsibilities

• Provide technical expertise and understanding on the qualification and requalification approach surrounding manufacturing and packaging related equipment as well as critical utilities and facilities.
• Provide technical expertise and understanding on the validation and revalidation of computerized systems including management information systems, laboratory instruments, and manufacturing control systems.
• Ensure all cGMP equipment, systems, utilities, and processes within the facility are maintained in a validated state.
• Collaborate with management to establish and meet targets and timelines. Manage competing priorities.
• Collaborate with R&D on new processes and product introductions and communicate validation requirements to ensure smooth transition between R&D to commercial.
• Schedule, plan, and disseminate tasks to support qualification/validation efforts, including auditing and technical review functions as defined within the MTI’s procedures, guidance documents and standard industry practices.
• Effectively communicate expectations and objectives to the Project Engineering and Automation teams, motivate team members, and build team camaraderie. Effectively communicate team activities, progress, priorities, etc. to site leadership.
• Establish project work priorities and timelines for the team. Delegate assignments and organize team meetings.
• Work interdepartmentally to assist and support scheduling qualification/validation activities.
• Provide sound rationale to validation strategies across multiple departments.
• Assess impact of change controls to qualified systems/facilities/equipment and validated products/processes.
• Provide input to revised and new policies and procedures to effectively guide validation efforts.
• Provide technical input for investigations into process/product issues and associated CAPAs in support of the qualification/validation deviations and review of design requirements for products and equipment.
• Maintain compliance with current applicable regulatory requirements and guidance's, i.e., 21 CFR 210-211, EudraLex Annex 15, and any other applicable domestic and international regulations.
• Provide expertise, leadership, and mentorship for projects involving facility, equipment/utility qualification, and process, packaging and/or cleaning validation. Must ensure all cGMP systems within the facility are maintained within a validated state.
• Lead and participate in the development and implementation of cross-functional initiatives.
• Provide input to the development of personal performance goals and departmental objectives. Generate and conduct semi-annual performance reviews.
• Interface with customers on project discussions, timelines, project deliverables, etc.
• Support of an annual Equipment Qualification/Validation budget and manage controllable expenses to ensure a positive budget variance.
• Time management skills are a must. Effectively manage personal activities and manage the timeliness of the matrix team as well as participate and/or lead/manage project related team activities. Report project status and team performance capability to cross functional team members and site leadership.
• Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
• Maintain a state of inspection readiness.
• Train personnel and internal customers on relevant departmental processes.

Minimum Qualifications

• Bachelor’s degree (B.S.) from a four-year college or university in a related field (chemistry, microbiology, engineering) and a minimum of ten years industry experience with at least eight years direct validation experience and 2 years direct supervisory or managerial experience. However, a combination of experience and/or education will be taken into consideration.
• Must possess knowledge of computers, printers, plotters and various test equipment as well as word processing software, and project tracking software. Must possess solid knowledge of Engineering Commissioning, Qualification, and Validation guidelines the ability to apply it in a practical manner. Ability to solve multiple problems and deal with many variables and deadlines. Ability to deal effectively with contractors and fellow employees.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is: $95,000 - $193,000.

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.