Validation Manager Job in Indianapolis 46268, Indiana US

Position Overview:

Responsible for the validation prog         Repsonsible for the volidation programs and support of all phases of plant operations including on-going operations and projects in the following areas:

1.                    Aseptic pharmaceutical manufacturing, filling and packaging

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

3.                    Analytical and Microbiological Laboratories

4.                    GMP related Computer Systems and Networks

Major Position Activities Responsibilities:


1.                    Define and manage all facets of a compliant validation program including:
Process Validation, Cleaning Validation, Shipping Validation, Computer System Validation, Laboratory Validation.

2.                    Manage the Revalidation Program for the site (processes, cleaning, laboratory, computer systems) and the Change Control for equipment, processes and facility.

3.                    Maintain an up to date media fill program and schedule covering all aseptic manufacturing and filling operations.


(Provide quantitative informational measures. ie: sales volume, staff supervised, budget dollar responsibility, approval authority, etc.)

Responsible for all staff in the validation departments, as well as contractors supporting individual projects.  Total direct reports: four employees.

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

Background Qualifications:

1.                    Education:
B.S./M.S. in a scientific discipline.

2.                    Experience:
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.  Ten or more years experience as professional and supervisor in production or technical support functions, preferably in an area with aseptic pharmaceutical manufacturing.
Proven people leadership and project management skills

3.                    Personal Skills:
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.

4.                    Other Requirements:
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.