Technical Services Scientist

summary/objective

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.

Essential functions:

• 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.

required skills/responsibilities

• 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.

required Qualifications:

• Bachelor's degree in Engineering/Science discipline.
• Minimum 3 years' experience in the pharmaceutical industry.
• Experience in manufacturing and packaging operations in a solid dose environment.
• Expertise in the principles of equipment design/operations and validation in the following preferred: facilities (including design, material, and personal flow analysis, HVAC/HEPA), utilities (including WFI & purified water, clean steam, compressed process air), Clean-In-Place system, solid dosage equipment, process and cleaning validation.

position type/expected hours of work
This is a full-time position.  Days and hours of work are Monday through Friday, but extended (earlier or later) work times or weekend work may be required. Validation activities require flexible hours to meet the manufacturing schedule.

physical demands

The employee may be required to sit at a computer or be on their feet for long periods of time.  The duties will require working around and on manufacturing equipment, requiring bending, squatting, climbing, and reaching above shoulder level. There are specific vision abilities, manual dexterity, and fine finger movement required by this position for Process Validation activities. This job requires the ability to lift fifty (50) pounds.

work environment

This job operates in professional office, laboratory, and manufacturing environments. The attire is dictated by the environment that you are working in (e.g., business casual attire for the office). This role routinely uses specialized equipment and instruments for obtaining samples and testing the functions of manufacturing equipment in support of validation activities. Standard office equipment and software is also routinely used.