Senior Validation Engineer or Specialist, Equipment

Role Summary

Senior Validation Engineer or Specialist, Equipment – on-site in Silver Spring, Maryland. Lead equipment validation activities across QC lab, upstream, downstream, and aseptic fill/finish manufacturing, developing sterilization cycles and validation protocols to ensure compliance and performance in a regulated environment.

Responsibilities

• Lead and execute equipment validation activities for manufacturing systems, including sterilization, qualification, and cleaning across various processes (Solid Dose, API, Biologics, Fill Finish, and packaging).
• Develop validation protocols from scratch and write comprehensive documentation to support compliance and inspection readiness.
• Collaborate with cross-functional teams to troubleshoot challenges and ensure validation milestones are met.
• Assess and ensure adherence to regulatory requirements from USFDA and EU related to validation activities.
• Communicate validation status effectively to colleagues and management, providing clear data presentations and updates.

Qualifications

• Required: Bachelor‚Äôs Degree in an engineering field.
• Required: 5+ years of relevant validation experience in a pharmaceutical/cGMP environment.
• Required: Ability to communicate clearly with cross-functional teams and management; strong written and verbal communication skills.
• Required: Detail-oriented, self-motivated, organized, with the ability to prioritize and adapt to change; capable of working with minimal supervision.
• Required: Working knowledge of validation datalogger software (Amphenol/Ellab preferred).
• Required: Working knowledge of USFDA and EU validation regulatory requirements; proficiency with word processing, spreadsheets, basic statistical software, and email software.
• Required: Ability to perform, review, and oversee equipment process, sterilization, and cleaning qualification for varied processes.
• Preferred: Experience with target systems including computerized information systems, manufacturing control systems (PLC, BMS, DCS, SCADA), and laboratory automation systems (robotics, chromatography networks, data acquisition).

Skills

• Strong project leadership and collaboration abilities.
• Analytical thinking and problem-solving in a regulated environment.
• Proficiency in data analysis, documentation, and technical writing.

Education

• Bachelor‚Äôs Degree in an engineering field.

Additional Requirements

• On-site work requirement at Silver Spring, Maryland location.