Manager, QA Validation at Millipore Corporation in Indianapolis, Indiana

Job Description:

Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-POEME Indianapolis Validation Engineering
Recruiter: Paul Therrien



This information is for internals only. Please do not share outside of the organization.




Your Role



This position will manage the validation programs and support of all phases of plant operations including
on-going operations and projects in the following areas:

• Aseptic pharmaceutical formulation, filling and packaging


• Critical and non-critical utility support services (Water for Injection, Compressed Air, Cooling Water, Steam, etc.)


• Analytical and Microbiological Laboratories


• GMP related Computer Systems and Networks

Major Position Activities & Responsibilities:

• Define and manage all facets of a compliant validation program including: Process Validation, Cleaning Validation, Shipping Validation, Computer System Validation, Process Media Simulation Program, Laboratory Validation and Equipment Qualification.


• Participate in projects for new systems and equipment. Associated functions include project estimating and budgeting, scheduling and overall project coordination.


• Manage the Revalidation Program for the site (processes, equipment, sterilization, cleaning, laboratory, computer systems, etc.)


• Develop project validation plans in support of small and large facility projects, including new product transfers, raw material qualifications, facility expansions, equipment and system acquisitions and modifications.


• Review process changes and validation in support of Annual Product Quality reviews.


• Perform Validation Review and Approval for all validation documents.


• Review and recommend impact of critical system work orders and change control requests (document changes, physical changes, etc.). Recommend required level of validation and propose plans to maintain systems in a compliant, validated state.


• Maintain the media fill program, covering all aseptic manufacturing and filling operations.


• Assume project validation lead to support projects managed by other departments.


• Create validation master plans for new systems/processes.


• Create Standard Operating Procedures (SOP's) and maintain/ update existing SOPs.


• Create and support the creation of protocols and summary report and technical assessments


• Acquire and demonstrate the ability to use site documentation systems such as: Quality Tracking System, Document management systems, Training, Maintenance management etc.


• Interpret study results and raw data. Identify trends, OOSs and determine validation impact


• Maintain a focus on continuous improvement and ensure that the validation program meets best accepted practices based on current industry and regulatory guidance


• Provide technical support on process and validation topics in support of compliance audits and investigations


• Support personnel development and growth of validation staff through training, mentoring, coaching, etc. Provide site-wide training as required to increase awareness and understanding of validation and the site validation program


• Performs special projects and other duties as assigned.


• Responsible for all aspects of validation program as described above.


• Responsible for all validation staff department, as well as contractors supporting individual projects.


• Responsible for Validation Expense Budgets, totaling approximately $750,000.

Who You Are




Minimum Qualifications:

• B.S./M.S. in a scientific discipline with 5 or more years of experience as a professional in production, validation, technical support or quality assurance functions.


• Experience with aseptic pharmaceutical manufacturing.

Preferred Qualifications:

• Proven people leadership and project management skills with at least five years supervising people


• In-depth knowledge of US and European GMP guidelines, federal environmental regulations, especially ICH 8, 9, 10 and the most recent Process Validation Guidelines issued by FDA.


• In-depth knowledge of process equipment, unit operations, process control systems.


• Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment, computer systems, process control systems, equipment cleaning, and sterility assurance required.


• Knowledge of various types of validation test equipment, such as: Kaye Validator, Val Probe, PLC, Temperature/Pressure standards.


• Prior experience in the qualification of various types of sterile filling facility equipment and systems


• Hands-on skills are necessary.


• Expertise with Windows based Personal Computers and above average PC skills with spreadsheets, word processing and databases.


• Employee must be self-motivated, highly organized, and conscientious. Must be able to work and make decisions independently as well as with a team. Must be able to work in technically and mentally demanding situations. Strong verbal and written communications skills are required.


• Employee must have sufficient mobility to work in a process environment. The employee will be required to climb stairs and ladders to perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


• Employee must be available to support off-shift and weekend activities to meet Validation objectives and provide technical support as required.


• Employee must be self-motivated, highly organized, and conscientious. Effective interpersonal skills are required to interface with internal clients as well as outside contractors. Must be able to work and make decisions independently as well as with a team. Must be able to work in technically and mentally demanding situations. Excellent verbal and written communications skills are required.


• Employee must have sufficient physical agility to work in a process environment, the employee will be required to climb stairs and ladders to perform the functions of this job.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. Apply Now