Associate Validation Engineer - Planet Pharma : Job Details

Job DescriptionSummary: Position may perform the following: documentation, analytical assessment, or data gathering. The primary responsibility of this position is for support of qualification documentation filing, preparation or any responsibility surrounding data collection. Other department tasks may involve thermocouple assembly / calibration, data collection, system updates and other tasks as assigned. Preferred excellent written and verbal communication skills, and ability to maintain cGMP compliance in accordance with worldwide guidance sources. Job Responsibilities: • Collects current equipment documentation to fill gaps or identify missing information. Working with Validation Engineers and quality assurance document control to implement necessary improvements. These may include modifications to existing documents, or collection and filing of current documents. • Supports validation protocols for data collection, or creating documents, as assigned. • Maintains compliance with regulatory agency guidance and company procedures. • Assists with execution of equipment validation studies to include protocol execution, data analysis up to including control system administration such as software backups and system updates. • Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.). • Drafts commissioning and qualification protocols to sufficiently demonstrate the process is designed and fit for the intended use • Supports on-going system requalification and continuous improvement activities governed by change management processes Skills: • Possess an understanding of documentation organization, and ideally in a GMP environment • Must have excellent verbal and written communication skills, attention to detail, and problem solving skills. • Must be experienced with Microsoft Office tools, i.e. Word, Excel, etc. • Desirable to also have some basic mechanical skills. • Preferred understanding of statistical analysis tools and/ or analytical methods. Education/Experience: • BS/BA Degree in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility. • 0 - 2 years pharmaceutical manufacturing experience. Pay ranges between $20-24.60/hr based on experience The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma. Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.