Validation Engineers II

MilliporeSigma; Indianapolis (IN); On-site; USD 110,000 - 131,000; Full time

Job summary

An established industry player is seeking a Validation Engineer II to support validation activities at their Indianapolis site. The role involves ensuring compliance with cGMP and FDA regulations while executing validation protocols for various processes and equipment. Candidates should possess a Bachelor's or Master's degree in Engineering and have substantial experience in the aseptic pharmaceutical sector. This is an exciting opportunity to contribute to critical validation projects in a dynamic environment, where your expertise will directly impact product quality and safety. If you are passionate about engineering and compliance, this role is perfect for you.

Qualifications

• 5+ years of experience in validation engineering in an aseptic pharmaceutical setting.
• Ability to create and execute validation protocols and SOPs.

Responsibilities

• Support all validation activities ensuring compliance with cGMP, FDA, and EU regulations.
• Research, write, and execute validation protocols including IQ, OQ, and PQ.

Skills

Validation Protocols

Statistical Analysis

Cleaning Validation

Process Validation

SOP Creation

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Tools

Kaye Validator

Val Probe

PLC Software

Temperature Mapping Equipment

Job description

Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-POEME Indianapolis Validation Engineering (1204795)
Recruiter: Ashley Hennessy

This information is for internals only. Please do not share outside of the organization.

NOTICE OF FILING

This notice is posted as the result of the filing of an Application for Alien Labor Certification with the Department of Labor for the job opportunity listed below. Any person may provide documentary evidence bearing on this Labor Certification Application to Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210.

Employer: Exelead Inc.

Employer Address: 400 Summit Drive, Burlington, Massachusetts 01803

Worksite Address: 6815 Guion Rd., Indianapolis, IN 46268

Job Title: Validation Engineer II

Job Duties: 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;
11. Perform peer review of all validation documents. Salary: One hundred ten thousand seven hundred sixty dollars to one hundred thirty thousand seven hundred sixty dollars per year.

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;
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)

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.