Validation and Documentation Specialist

ATS Automation Tooling Systems Inc. • Warminster, PA

79d • Onsite

About The Position

SP Industries Inc. 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.

Requirements

• 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).
• 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.
• 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.

Nice To Haves

• Experience using Microsoft Word/Excel/Visio, Articulate Storyline and/or Adobe Presenter, as well as SolidWorks or other 3D modeling software is highly desirable.

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.

Benefits

• We provide a wide range of innovative and high-quality scientific products that improve people's lives
• We offer a robust health and welfare benefits package that includes Life, Health, Dental, Vision
• We offer 401(K) including company match, Paid Time Off annually + Paid Holidays
• You will enjoy career Advancement Opportunities and Tuition Assistance to help you achieve your goals and continue your career growth

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Machinery Manufacturing
• Number of Employees: 5,001-10,000 employees