Validation & Documentation Specialist

ATS Scientific Products  is seeking a full‐time Validation and Documentation Specialist in Warminster, PA to create and maintain various technical documents (e.g., user manuals, equipment specifications, testing protocols, etc.) as well as execute factory testing protocols for pharmaceutical and biotechnology products and services. This role is based on‐site. Occasional travel may be required.
 

Primary Responsibilities

• Research, outline, write, and edit content, working closely with various departments to understand project requirements.
• Gather information from subject‐matter experts and develop, organize, and write procedure manuals, technical specifications, and process documentation.
• Work with development and support leads to identify documentation repositories, revise and edit, and determine best solutions for data compilation and centralized storage.
• Ensure the timely development, execution, and coordination of all validation activities pertaining to facility, equipment, and process in compliance with quality system requirements, site procedures and regulatory requirements.
• Compile relevant commissioning/qualification/validation study data and generate summary reports.
• Manage responsibilities/workload to assure accurate and timely documentation and testing execution.

Skills

• Excellent written and verbal communication skills with an ability to understand and communicate
• complex technical concepts clearly and logically.
• Strong research skills including gathering data from multiple sources (subject matter experts).
• Must possess excellent analytical skills, good problem‐solving technique and data analysis skills.
• Proficient in desktop publishing and using common authoring tools such as Adobe Acrobat and MS Office.
• Superb interpersonal communication skills. Ability to collaborate within a team environment with cross‐functional peers to support deadlines and handle multiple projects simultaneously.
• Advanced capabilities in screen capture and graphics modification.
• Must be able to use various testing equipment i.e. data loggers, multimeters, etc.
• Must be able to demonstrate and follow Good Documentation Practices (GDP).

Education and/or Experience

• Bachelor’s Degree in engineering and/or science‐related discipline with an emphasis on technical and/or process documentation or equivalent years of relevant experience. (Technical writing/validation experience for pharmaceutical or biotechnology products preferred.)
• One to three years’ experience writing technical and/or similar documentation and executing validation protocols.
• Experience using Microsoft Word/Excel/Visio, Articulate Storyline and/or Adobe Presenter, as well as SolidWorks or other 3D modeling software is highly desirable.
• Highly motivated individual possessing a mix of technical and language skills with strong attention to detail.
• Ability to grasp complex products, technologies, tools or knowledge and learn quickly.
• Interest in producing and maintaining standardized, accurate, and effective technical documentation.
• Interest in executing testing protocols.
• Flexibility concerning project deliverables.
• Self‐starter, competent at working independently with minimal supervision.

HSE

All employees have the responsibility to work in a safe manner and report any health, safety or environmental concern to their manager or supervisor in a timely manner.

Employee responsibilities for Health, Safety and Environment include:

• Work in compliance with divisional health, safety and environmental procedures
• Refrain from removing or altering safety devices or guarding unless hazardous energies are controlled through lockout-tagout methods
• Report any unsafe conditions or unsafe acts 
• Report defect in any equipment or protective device
• Ensure that the required protective equipment is used for the assigned tasks
• Attend all required health, safety and environmental training
• Report any accidents/incidents to supervisor
• Assist in investigating accidents/incidents
• Refrain from engaging in any prank, contest, feat of strength, unnecessary running or rough and boisterous conduct