Senior Validation Manager

Kindeva Drug Delivery • St. Louis, MO

33d • Onsite

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The successful candidate will provide strategic and tactical support to all managers and professionals in support of equipment validation business needs. Will be an SME regarding current GMPs, Regulatory/CMC, deviation investigations, lot release, regulatory audits, change management, and contemporary product and process validation. Will support the quality strategy and drive changes to support improvements within the business across all sites. The candidate will also maintain appropriate contacts to access additional information regarding the overall pharmaceutical and medical device compliance landscape. This position leads a team of validation engineers directly or using site leads/managers with a wide range of responsibilities within validation and change management.

Requirements

• BS/MS or PhD in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science
• 10+ years of related experience
• Previous management experience (leading first line supervisors and managers preferred) including experience managing in at least several of the following: cGMPs, Regulatory (worldwide), deviation investigation, drug product lot release, GMP Audit support, technical product transfers, change control management, equipment qualification, cleaning validation, computerized systems validation, and product and process validation.
• A robust working comprehension of the theory and function of pharmaceutical equipment and systems is required. These may include sterilizers, depryrogenation ovens, washers, WFI, HVAC systems, aseptic filling equipment, incubators/refrigerators, cleaning equipment, inspection equipment, assembly equipment, labeling/packaging equipment, data recorders and personal computers.
• Knowledge of contemporary validation guidelines for pharmaceutical industry. Ability to read, analyze and interpret common scientific and technical journals, financial reports (as needed), and legal documents; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; respond to regulatory agencies; and respond to complaints from customers.
• Ability to define problems, collect data, establish facts, and draw valid conclusions; interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract or concrete variables.
• Ability to gather and analyze information skillfully and present in many forms. Should have the ability to perform advanced mathematical concepts such as exponents, logarithms, quadratic equations (as needed), and apply mathematical operations to such tasks such as frequency distribution, CpK, determination of test reliability.
• Excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.
• Demonstrated proficiency in organizational and project management skills and ability to balance multiple priorities.
• Advanced knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects).

Responsibilities

• Equipment Qualification: Support all product and process validation and equipment qualification at the site while following industry contemporary standards. Develop and maintain a Site Validation Master Plan and a Periodic Review program.
• Product and Process Validation: Support all product and process validation and equipment qualification at the sites.
• Support the development of a Site Validation Master Plan and a Periodic Review program.
• Audits and Inspections: Organize and lead the support of regulatory and internal audits as they relate to Validation and Change Management Program. SME for validation related topics during regulatory inspections, develop responses to potential findings, and assure timely completion of corrective actions and commitments.
• Site Change Management Program: Responsible to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings. Review and approve all proposed changes impacting finished products, equipment, processes and facilities.
• Cleaning Validation: Ensure that all cleaning processes are qualified, and those products processes of being enhanced are validated appropriately. Develop and maintain a Cleaning Validation Master Plan.
• This position is responsible for resource projections and budget preparations. Also, responsible to provide or oversee the preparation of project cost estimates, and will provide support and GMP review for major site capital projects.
• Responsible for the development, mentoring, and performance management of a validation team. Fostering a culture where colleague engagement thrive leading to a commitment to manufacture more tomorrows for our customers.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees