Per client requirements, all candidates must have a minimum of a bachelor's degree AND 4 years of applicable field experience, or in lieu of a Bachelor's degree, a minimum of 8 years of applicable field experience.

Responsibilities include, but are not limited to:

   - Generate and execute qualification and re-qualification protocols and  reports, (IQ/OQ/PQ/RQ), for the validation of new and existing equipment and utilities.

   - Develop acceptance criteria consistent with industry standards, manufacturer recommendations, user and functional specifications, and current Good Manufacturing Practices (cGMP).

   - Generate summary reports, following Good Documentation Practices.

   - Use Kaye AVS or Veriteq dataloggers for thermal mapping studies.

   - Generate/revise Standard Operating Procedures (SOPs).

   - Analyze data for adherence to acceptance criteria.

- Document and resolve deviations associated with qualification studies.

   - Assist with commissioning, FATs, and SATs when applicable.

   - Generate technical documents such as reports, gap analyses, and risk assessments.

   - Provide technical and/or investigational support in troubleshooting and resolving manufacturing equipment issues.

   - Perform technical reviews of qualification documents performed by others.

   - Support services to prepare for audits.

Education:

Bachelor of Science degree in Engineering or applicable scientific field.

Candidates with applicable validation experience in GMP

biotechnology/pharmaceutical manufacturing environments are also considered.

Experience & Skills:

   - Must be organized, detail oriented, and have strong communication skills.

   - Must have the ability to manage multiple projects.

   - Must have excellent written and verbal skills.

   - Must have experience and knowledge of aseptic processing.

   - Must have understanding and hands on experience in the use of computer programs such as Microsoft Office, EDMS, RAM, LIMs.

- Must be able to work independently as well as in a team environment.

   - Must have working knowledge of cGMPs.

   - Must have working knowledge of sterilization equipment, clean room environments, cleaning processes, critical utilities (HVAC, WFI, RO, CCA, etc) computerized control systems, and isolator technology.

   - A general knowledge maintenance and calibration procedures is desirable.