Validation Engineer

Adare Pharma Solutions Recruiting Team•Vandalia, OH

About The Position

In this position, the Engineer will utilize their formulations and/or technical services background to support Manufacturing. Responsibilities encompass technical knowledge in support of solid oral dose manufacturing. As a collaborative partner, they will utilize their expertise in all aspects of product scale up, contract manufacturing, validation and technical support of 3rd party manufacturing as well as internal support of solid oral dose facilities in North America. Will be a key contributor and practitioner in lean manufacturing projects across multiple sites and manage various transfer and scale-up projects throughout the supply chain.

Requirements

BS/BA degree from a four-year accredited university or college in Biology, Chemistry, Engineering, or related field; plus 3-5 years of related experience required.
Possess mechanical aptitude
Must have good working knowledge of the “Good Manufacturing Practices”
Ability to continually learn on the job: new equipment, new manufacturing technologies, new raw materials, etc.
Problem solving and trouble-shooting abilities. Ability to determine the root causes of failures and problems.
Capable of scientific observation of processes; has ability to accurately record observations and draw conclusions from them.
Technical writing ability. Ability to explain scientific and technical issues to a non-specialist audience.
Excellent interpersonal written and oral communication skills.
Proficient in Microsoft Office – Word, Excel, PowerPoint, Visio. Statistical software such as JMP.
Ability to coordinate, contribute to, and work within cross-functional teams.
Able to prioritize duties and work on multiple projects with minimal supervision.
Possesses good attention to detail and excellent organizational skills.
Demonstrates mechanical aptitude.
Operate independently and provide feedback and solutions to technical issues for both internal projects and projects at 3rd party sites.
Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
Works in a cooperative manner with managers, supervisors, coworkers, customers, and the public.
Works effectively under deadlines.

Responsibilities

Manage scale up of commercial products, manufacturing feasibility batches, writing batch records and summarizing results for both internal and 3rd party manufacturing.
Develop and execute studies for process, equipment, and cleaning validation activities related to bulk drug delivery and finished dosage formulations developed by Research and Development (R&D),products currently in commercial production, and technical transfers from customers or other Adare sites. These activities will be executed to Adare, customer, and regulatory, domestic and foreign, requirements.
Provide technical training and support to departments supported by the Technical Services/Validation departments (Third party GSC, Manufacturing, etc).
Update, review, and approve Standard Operating Procedures (SOPs), batch records, and other official documents and determine if validation or re-validation is required prior to approval of the new or changed procedure(s). Recommend new procedures or revisions as applicable.
Participate in Factory Acceptance Testing (FAT) and/or due diligence testing and investigations.
Collaborate with validation projects within the facility including execution of protocols and report writing.
Technical experience and/or expertise in the operation of pharmaceutical equipment including but not limited to tablet presses, blenders, fluid beds, roller compactors, pan coaters, mixers, ovens, capsule fillers, packaging equipment, and other pharmaceutical equipment.
Operate independently and provide feedback and solutions to technical issues for both internal projects and projects at 3rd party sites.
Support the engineering department with capital projects or trouble shooting of equipment and processes within the facility.
Be a key contributor and practitioner of lean manufacturing programs within the facility.
Attends work on a regular and predictable basis.
Completes assigned tasks in a safe manner and in a constant state of alertness.
Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
Works in a cooperative manner with managers, supervisors, coworkers, customers, and the public.
Works effectively under deadlines.