Technical Service Scientist

The Technical Services Scientist is responsible for developing, organizing, leading, and performing qualification and validation activities. The Technical Services Scientist also performs related technical writing functions, including Standard Operating Procedures., * Leads all phases of validation. With minimal supervision, evaluates projects for validation requirements, determines validation project timelines and priorities, develops protocols, and completes approval, execution, and reporting. Provides guidance and technical information to others. Supports project scope development activities with Engineering, verifies operating parameters during OQ, and coordinates with testing participants during all validation activities. Supports the writing of SOP’s as new processes are developed, and serves as subject matter expert on the assigned areas, as needed.

• Writes, reviews, and approves validation documents and SOP’s for selected projects. Adheres to project schedules for all assigned activities.
• May lead validation activities for projects that can encompass multiple protocols.
• Authors and reviews new procedures or incorporates changes to existing standard operating procedures, describing validation principles, activities, and training.
• Lead member in site validation activities. Works with other departments (QA, Manufacturing, Engineering, Analytical Sciences, and Metrology) to support site projects.
• Reviews engineering drawings (P&IDs, construction, as-built, flow diagrams) for accuracy and compliance with GMP/Validation principles and provides feedback to engineering for any noted deficiencies or improvements.
• Performs and reviews validation testing as required.
• Reviews validation packets for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. Compares results against acceptance criteria and brings exceptions and deviations to management’s attention. Initiates Discrepancies or Deviations and resolves.

Do you have experience in Technical documentation?, * Strong interpersonal and leadership skills necessary to communicate clearly and effectively and coordinate qualification/validation activities with all levels of personnel from various disciplines, including Manufacturing Operations, Quality Assurance, Analytical Sciences, Engineering, Facilities, and Regulatory Affairs.

• Adept at use of personal computers and various software programs (e.g., Word, Excel), for data acquisition, statistical analysis of validation data, and word processing.
• Proficient in protocol development, data analysis, and report writing.
• Understanding of statistics and their use in qualification and analysis

Pulled from the full job description

• Parental leave
• 401(k)
• Health insurance
• Retirement plan
• 401(k) matching
• Paid time off
• Vision insurance, * 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance