Senior Specialist, Engineering- Validation

Responsibilities:
- Provide leadership and technical support for Steam Sterilization, Dry Heat Depyrogenation, Steam Decontamination, Vaporized Hydrogen Peroxide Decontamination, CTU and Warehouse Temperature Mapping, and Performance Qualification (PQ) Validation.
- Schedule and execute PQ validation activities and manage PQ protocol close-outs.
- Perform technical investigations/analyses; troubleshoot PQ execution.
- Recommend and implement corrective actions; evaluate/change control; support QMS alignment.
- Review procedural revisions for regulatory compliance; write/review final reports and procedures.
- Conduct data analysis and Second Person Review.
- Present SME information to regulatory inspectors; interface with Project/IPT customers to manage challenges.
- Maintain team accomplishment metrics and manage contractors/P1/P2 staff (headcount justification, hiring support, prioritization, feedback/coaching, year-end assessments, and safety/quality compliance excellence).

Qualifications:
- BS/MS in biology, biochemistry, biochemical/biological/biomedical engineering, chemical engineering, computer science, integrated science, or related life science/engineering.

Required Experience & Skills:
- 5+ years pharmaceutical manufacturing in a cGMP environment.
- Demonstrated problem-solving with a hands-on, field-oriented approach.
- Strong technical, organizational, interpersonal, and communication skills.
- Experience/knowledge: CTU/WH qualification/validation; Dry Heat Depyrogenation qualification/validation; Steam Sterilization/Sanitization qualification/validation; VHP decontamination qualification/validation.
- Experience acting as a team leader.

Required Skills:
- Biochemistry, biopharmaceutical industry, GMP, pharmaceutical manufacturing, steam sterilization, temperature mapping, validation.

Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on the posting).