Validation Director

Simtra BioPharma Solutions; Bloomington (IN); Vor Ort; USD 150.000 - 185.000; Vollzeit

Benefits dieser Stelle

Medical & Dental Coverage

401(k) Plan

Paid Time Off

Parental Leave

Education Assistance

Employee Assistance Program

Zusammenfassung

Simtra BioPharma Solutions in Bloomington, IN, seeks a Validation Director to lead the site’s validation functions within the senior leadership team, reporting to the Site Director. This on-site role covers commissioning through PQ and aligns with global regulatory expectations for GMP operations.

You will shape validation strategies, manage budgets (> $10MM), oversee processes for new equipment and client products, and collaborate with Quality and Regulatory to ensure inspections pass with

Qualifikationen

• Bachelor’s Degree in technical discipline required, preferably in science or engineering.
• Minimum 10 years of experience in aseptic manufacturing operations.
• 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

Aufgaben

• Lead the Validation organization supporting the manufacturing operations from Commissioning and Qualification through Performance 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.
• 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

Kenntnisse

Aseptic processing knowledge

Validation leadership

Cross-functional leadership

Regulatory compliance understanding

Budget management

Ausbildung

Bachelor’s degree in science/engineering

Tools

Quality enterprise software

Jobbeschreibung

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

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]:

• 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.

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval, or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.