Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.
The role
The Bloomington facility is a full-service contract manufacturing plant providing formulation, aseptic filling and finishing services. The Validation Director is a member of the plant senior leadership team and is responsible for the Validation functions. This position reports to the Site Director.
This position is on site 5 days per week in Bloomington, Indiana
The responsibilities
Lead the Validation organization supporting the manufacturing operations from Commissioning and Qualification through Performance Qualification. The teams comprising the organization are Sterility Assurance Validation, Cleaning Validation, Computer Systems Validation and Commissioning and Qualification.
Deploy Validation strategies in compliance with global regulatory requirements
The Validation disciplines are responsible for designing and validating processes for new equipment and new client drug products onboarded, maintaining the validated status for GMP processes throughout the facility, and representing Simtra in client and regulatory inspections.
There are currently 3 manufacturing facilities with 5 active filling lines and supporting process equipment. 1 clinical scale fill machine will be added in the next 18 months.
1 additional manufacturing facility is currently undergoing commissioning and qualification with 1 isolated syringe line. 1 more syringe line and 1 vial line with 3 lyophilizers is in plan
1 other manufacturing facility is in the early construction phases with plans for another 6+ filling lines likely within a 5-7 year period
Direct the development and implementation of new processes requiring new technologies
Budget development and ownership (>$10MM)
Responsible for final approval on product / process documentation, including CAPAs, deviation investigations and change controls
Responsible for strategic planning, deployment, execution and after-action reviews
Represent the site during regulatory inspections, client visits, and internal audits
Collaborate with site Quality to drive improvements and risk reduction
Required qualifications
Bachelor’s Degree in technical discipline required, preferably in science or engineering
Minimum 10 years of experience in aseptic manufacturing operations required
Minimum 8 years of experience in Validation
Minimum 8 years of technical management experience including cross-functional teams, resource and budget management and strategic development experience
Strong knowledge of aseptic processing and validation in a globally regulated industry (FDA, EMEA, PIC/S, Japan PMDA, etc.)
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use quality enterprise software systems
Physical / Safety Requirements
Duties may require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Position requires sitting for long hours but may involve walking or standing for periods of time
Ability to meet Grade C gowning requirements
Global travel may be required (<10%)
In return, you’ll be eligible for[1]
Day One Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Employee Ownership Plan
Additional Benefits
Short and Long-Term Disability Insurance
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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