Sr. Process Validation Engineer

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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.

This role:

The Senior Process Validation Engineer is a key member of the Technical Services organization responsible for leading and supporting validation activities for sterile injectable manufacturing processes within a regulated pharmaceutical CDMO environment. This role focuses on process validation strategy execution lifecycle management and maintaining the validated state to ensure compliant robust and inspectionready operations.

The Senior Process Validation Engineer partners closely with Manufacturing Quality Validation Engineering Tech Transfer Supply Chain and Regulatory teams to implement riskbased approach that support safe reliable and scalable sterile drug product manufacturing. This position is full time and based onsite at the Simtra Bloomington facility.

The responsibilities:

• Provide technical and strategic leadership for process validation of new and existing sterile injectable manufacturing processes including formulation compounding filtration aseptic filling lyophilization and terminal sterilization as applicable
• Own and drive lifecycle process validation strategy ensuring riskbased scientifically justified approaches aligned with FDA/EMA guidance ICH expectations and internal quality standards
• Lead the development review and approval of key validation deliverables including Process Validation Master Plans risk assessments protocols control strategy elements and final validation summary reports
• Set validation direction and standards for parameters sampling strategies acceptance criteria and statistical approaches; ensure consistent application across products programs and manufacturing areas
• Serve as the primary validation interface with Manufacturing Quality Engineering and external clients to ensure endtoend process readiness for PPQ and commercial manufacturing
• Lead process validation planning and execution for technology transfers including assessment of development history identification of validation gaps definition of validation scope and readiness for PPQ execution
• Provide senior oversight and technical guidance for equipment facility and utility qualification activities ensuring robust alignment with process validation requirements
• Provide expert validation impact assessments for changes related to process equipment raw materials analytical methods and facilities supporting change control and regulatory commitments
• Establish and oversee continued process verification programs
• Act as onthefloor validation lead during PPQ execution process confirmation runs technology transfer campaigns and highrisk or highvisibility manufacturing operations
• Ensure validation documentation is inspectionready supporting internal audits client audits and global regulatory inspections
• Serve as a SME during regulatory inspections and client audits; lead inspection preparation participate in interviews and support responses to inspection observations
• Continuously improve validation practices incorporating lessons learned regulatory trends and industry best practices to enhance efficiency compliance and product quality

Required qualifications:

• Bachelors degree in Engineering Life Sciences or a related technical discipline
• 58 years of experience in process validation CQV MS&T or manufacturing support within a regulated pharmaceutical environment
• Strong understanding of sterile injectable manufacturing processes and aseptic processing principles
• Solid working knowledge of cGMP requirements and validation lifecycle concepts
• Demonstrated experience authoring and executing process validation protocols and reports

Preferred qualifications:

• Experience working in a CDMO environment and sterile injectable drug product manufacturing
• Familiarity with equipment and facility qualification and CSV validation
• Experience supporting regulatory inspections and client audits as a validation SME
• Knowledge of continued process verification process capability analysis and lifecycle management
• Experience working with electronic validation systems MES or electronic batch records

Physical / safety requirements:

• Occasional overtime may be required including evenings or weekends to support validation execution or manufacturing schedules
• Position requires extended periods of sitting with routine walking and standing in manufacturing areas
• Must be able to qualify for classified manufacturing area gowning as applicable
• Must be able to wear required personal protective equipment (PPE)

In return youll be eligible for1:

• 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
• 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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