Validation Engineers II

Job Title: Validation Engineers II

Employer: Exelead Inc., 400 Summit Drive, Burlington, MA 01803

Job Location: Exelead Inc., 6815 Guion Rd., Indianapolis, IN 46268

This position is eligible for the Exelead Inc. Employee Referral Program.

Job Responsibilities:

The Validation Engineer II is responsible for providing support to all validation activities at our Indianapolis worksite. The position is responsible for compliance with all applicable cGMP,

FDA, and EU regulations as they pertain to validation (21 CFR 210 & 211; 21 CFR Part 11; EU GMPs; ICH Q7, Q8, Q9, Q10).

Specific duties include the following:

1. Research, write, coordinate, and execute validation protocols including IQ, OQ, PQ for process, equipment, facility, utility, computer, and cleaning validation;
2. Execute validation test functions in support of approved protocols;
3. Review, summarize and present data in a Summary Report for management review and approval, and perform revalidations;
4. Use validation test equipment such as Kaye Validator, Val Probe, PLC Software such as A-B and Honeywell, and Heat Blocks;
5. Acquire and demonstrate the ability to use site documentation systems such as: Quality Tracking System, Document management systems, Training, Maintenance management etc.;
6. Review and recommend impact of change control requests;
7. Apply statistical tools and analyze results and raw data;
8. Participate in projects for new systems and equipment;
9. Review process changes and validation in support of Annual Product reviews;
10. Create Standard Operating Procedures (SOPs) for new equipment/processes, as well as update existing SOPs; and
11. Perform peer review of all validation documents.

Job Requirements:

Employer requires candidate to have a Bachelor’s degree in Engineering or a closely related science field and five (5) years of progressively more responsible work experience in a

validation engineer or closely related occupation in an aseptic pharmaceutical setting.

Alternatively, employer will accept a Master’s degree in Engineering or a closely related science field and two (2) years of work experience in a validation engineer or closely related

occupation in an aseptic pharmaceutical setting.

Candidate must also have the following:

1. Demonstrated ability in the qualification of various types of sterile filling facility equipment, such as Sterilization Technology (Steam, Dry Heat, VHP, etc.), Temperature Mapping (Various chambers), Aseptic Equipment (Washers, Tunnels, Cappers, RABS, Isolators etc.), and Pharmaceutical-Grade Utilities gained through two (2) years of work experience;
2. Demonstrated knowledge of various types of validation test equipment, such as Kaye Validator, Val Probe, PLC, and Temperature/Pressure standards gained through two (2) years of work experience;
3. Demonstrated ability with process validation and cleaning validation gained through two (2) years of work experience;
4. Demonstrated ability researching, writing, coordinating, and executing validation protocols including IQ, OQ, and PQ for process, equipment, facility, utility, computer, and cleaning validation gained through two (2) years of work experience; and
5. Demonstrated ability creating Standard Operating Procedures (SOPs) for new equipment/processes, as well as updating existing SOPs gained through two (2) years of work experience.

Must be willing to work late-night and/or weekend shifts approximately 2-4 times a month to support the Validation Schedule.

All years of experience may be gained concurrently.

Applicants can mail resumes to Exelead Inc., 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: req# 286723 or apply online at https://www.emdgroup.com/en/careers/job-search.html)