Validation Director

simtrabps; Bloomington (IN); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

Supplemental Life Insurance

Spouse Life Insurance

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Validation Director to lead the Validation organization across commissioning, qualification and performance qualification, ensuring GMP compliance for multiple manufacturing lines.

You will own the budget (> $10MM), drive strategic validation programs, and represent the site during regulatory inspections and client visits, collaborating with Quality and Operations to drive risk reduction and process improvements.

Qualifications

• Bachelor's Degree in technical discipline required.
• Minimum 10 years of experience in aseptic manufacturing operations.
• Minimum 8 years of experience in Validation.
• Minimum 8 years of technical management including cross-functional teams, resource and budget management and strategic development.

Responsibilities

• Lead the Validation organization supporting manufacturing operations from Commissioning to Performance Qualification.
• Deploy Validation strategies in compliance with global regulatory requirements.
• Design and validate processes for new equipment and client drug products onboarded, maintaining GMP validated status.
• Direct development and ownership of the budget (> $10MM).
• Represent the site during regulatory inspections, client visits, and internal audits.

Skills

Aseptic manufacturing

Validation leadership

Cross-functional leadership

Budget management

Regulatory compliance

Quality software systems

Education

Bachelor's degree in science or engineering

Tools

Quality enterprise software systems

Job description

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.

Why join Team Simtra? Because we:

• 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 (

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 Lif