Manager Validation

Merck•Indianapolis, IN

5d•Onsite

About The Position

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

Requirements

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.
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.

Nice To Haves

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

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.