Search Jobs
Manufacturing Execution System Recipe Author
Job Description
The ITOT Team in Hillsboro is supporting Hillsboro Technical Operations (HTO) which is the commercial Make Assess and Release (MAR) and launch site for North America and Hillsboro Individualized and Cell Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.
The role will support the Hillsboro Technical Operations (HTO) team, located in Hillsboro Oregon, which is a Drug Product manufacturing facility (Component Prep & Compounding, Liquid/Lyophilized Filling, automated/Manual Inspection, Packaging/Finished Products and Distribution.) This role would perform Recipe Author activities for the operations that utilize MES in support of Tech Transfer projects.
Responsibilities:
- Manufacturing Execution System (MES) (PharmaSuite) recipe authoring and software development Troubleshooting plant floor MES execution and business system integration issues Compliance with corporate and site business processes, valid design principles, and quality procedures Qualification test plan development/review/approval and execution Implementing production tech transfer requirements into MES system Knowledge on batch record structure and exception handling, with sharing among the broader project team and affected site personnel
- Understanding of the Core practices that need to be adopted at the site, including recipe requirement documentation, validation, project deliverables such as project and implementation plans, etc.
- Development of recipe and workflow requirement specifications, formal design specifications of system master data configuration.
- Create, as directed, project-specific documentation required for implementation. Creation and finalizing recipe requirement specifications for all recipes and workflows Contributing to the development and optimization of departmental and site business processes Provide Consulting with Business Process owners in the Value Streams Contribute with MES Recipe Authoring knowledge to Projects/Squads for MES Projects, process improvement initiatives or support
Qualifications / Requirements:
A BS/MS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent A minimum of 5 to 7 years of manufacturing execution systems experience, preferably PharmSuite Strong interpersonal communication skills Project management skills Ability to multi-task while handling routine and impromptu assignments with minimal supervision Must be able to plan and perform testing, including documenting test conditions, expected results, and test validation Must be comfortable working under pressure, delivering quality results with schedule deadlines and have a proven track record in meeting schedule for tasks while still meeting or exceeding business requirements and goals Work autonomously direct with Engineering and Value Streams Work with Global Recipe Authors Team on common templates for PharmaSuite MES Job duties include after hours on call support at least one week a month
Pay Rate Range: $70-100/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Hillsboro, OR
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.