Manager Validation

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Merck Group is hiring a Manager Validation to lead the site wide validation program at MilliporeSigma in Indianapolis, full-time onsite, spanning aseptic formulation and filling, utilities, analytical and microbiological labs, and GMP computer systems. Ideal candidates hold a BS or MS in a scientific field with 8+ years in production, validation, or QA, plus five years of people leadership and strong knowledge of US and European GMPs and FDA Process Validation guidelines (ICH 8 9 10). You will define and manage validation master plans, drive projects and revalidation, review changes, support audits, mentor staff, and manage budgets. External applicants must be eligible to work in the US; pay range $139,100 to $208,700. Tips: tune your resume to quantify impact, highlight aseptic manufacturing and cross functional leadership, and be ready for off shift. Apply now.

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

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.
• Support 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.

Scope:

• 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

Who You Are

Minimum Qualifications:

• B.S./M.S. in a scientific discipline with 8 or more years of experience as a professional in production, validation, technical support or quality assurance functions, some in an area with aseptic pharmaceutical manufacturing.
• 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.

Preferred Qualifications:

• 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 accommodation 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.

Pay Range for this position: $139,100- $ 208,700

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The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

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