What are the responsibilities and job description for the Validation & Documentation Specialist position at ATS Automation Tooling Systems?
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
Education and / or Experience
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 :
Why Scientific Products? The three parallelograms in our logo reflect our core company values : People, Process, and Performance . As part of ATS, Scientific Products leverages the ATS Business Model (ABM) to train, develop, engage, empower, and energize our people to make impactful changes in the organization. Our relentless focus on people is what continues to set us apart as a great place to build a career.
ATS is a $2.2B publicly-traded global enterprise with a proud 40-year history of helping advance the future with automation solutions. Scientific Products sits within the ATS Life Sciences Group and is a leading global provider of state-of-the-art fill-finish drug manufacturing solutions, research, pilot and production lyophilizers, laboratory equipment and supplies, and specialty glassware. Scientific Products supports research and production across diverse end-user markets including pharmaceuticals, life science, ophthalmic, environmental testing and monitoring, food and beverage and more. Scientific Products has a long and successful track record of quality and science innovation, and is headquartered in Warminster, Pennsylvania, with production facilities in the USA and Europe. Scientific Products offers a world-wide sales and service network including product training and technical assistance. For more information visit www.scientificproducts.com.
EEO and Affirmative Action Statement :
SP is an Equal Opportunity Employer, dedicated to a policy of non-discrimination in employment on any basis and takes affirmative action to ensure equal employment opportunities. It is our policy to provide our employees and applicants with equal employment opportunities in accordance with applicable laws and not to discriminate on the basis of race, color, religion, ancestry, national origin, age, marital status, sex, gender identification, sexual orientation, genetic information, political belief, pregnancy, citizenship, handicap or disability, status as a veteran or member of the U.S. military, or any other characteristic protected by applicable federal, state, or local laws. SP's Affirmative Action Plan is available through the HR Department and may be accessed during normal business hours.
Pay Transparency Nondiscrimination Provision :
SP will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
