This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with the client and the cross functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Process Validation Sr. Manager.
The responsibilities:- Support and maintain the process validation program.
- Develop, revise, and maintain process validation procedures, protocols, and summary reports.
- Partner with clients and internal teams to define validation scope, requirements, and objectives.
- Design, execute, and analyze technical studies using statistical tools to establish and evaluate process parameters.
- Perform risk assessments to support process validation activities.
- Plan, coordinate, and execute process validation activities for new and existing products.
- Analyze validation data and prepare documentation to support validation conclusions.
- Conduct annual reviews and Continued Process Verification (CPV) activities to ensure ongoing process performance.
- Lead or support investigations related to validation activities, including Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
- Monitor regulatory requirements and industry best practices to ensure compliance and continuous improvement.
- Create and maintain visual management tools and controls for the Process Validation group.
- Serve as a Subject Matter Expert (SME) for process validation during regulatory, client, and internal audits.
- Develop industry expertise and project proficiency while working independently on assigned initiatives.
- Identify and implement opportunities to optimize departmental processes and improve operational efficiency.
Required qualifications:- Bachelor's degree required, preferably in a science or engineering-related field.
- Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
- Ability to communicate effectively at all levels.
- Sound industry knowledge, project proficiency, and be able to work independently. May be considered a subject matter expert (SME) in various disciplines.
- Must be able to identify opportunities for optimization of processes within the department or the plant.
- Ability to work independently or in teams.
Physical / Safety Requirements:- Duties may require overtime work, including nights and weekends
- Must be able to gown for Grade C environments
- 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.
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
DisclaimerThis 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.
