Technical Services Engineer
Founded in 2000, Tris Pharma, Inc. is a technology driven, specialty pharmaceutical company. With our intense focus on the application of physical chemistry in the biological systems, coupled with the requirements of manufacturing and market demands, we have grown our employee base over 250% in the past three years. We have an immediate opening in our Technical Services department for either an entry level or intermediate level professional. This is an exciting opportunity for a strong technically minded individual to work/build experience in pharmaceutical manufacturing environment. Job title and level determination will be commensurate with experience.
Technical Services provides direct validation support to pharmaceutical development and manufacturing operations. The incumbent assists and supports validation activities accurately and completes appropriate documentation fully and compliantly in accordance with current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA) requirements. She/he may assist in Validation projects that may include, but are not limited to: new product launches, Alternate API/Excipient qualification, scale up/down, submission batches, technical transfers, process improvement projects, process validation, cleaning validation, and other projects as necessary.
This is an Office and Manufacturing based position.
This is a 1st shift position but requires the flexibility to work periodically on 2nd or 3rd shift for short periods based on validation project needs.
· Responsible for assigned aspects of Validation activities, including writing protocols, records and reports, complying with cGMPs, SOPs and FDA requirements
• Responsible for executing, or participating in, scale-up/process validation activities which may include, but are not limited to: coordinating, manufacturing, sampling required batches as indicated in the protocol or batch record
• Assists with the development and writing of SOPs, Master Batch Records and other appropriate documentation and contributes to the circulation of the documents under approved procedures
• Performs and assists with other Validation tasks and activities as instructed by Technical Services Scientists and/or managementRequirements
· Bachelors degree in science or technology related discipline (Engineering, Chemistry, Pharmacy, etc.) REQUIRED. Masters degree PREFERRED
· Minimum 2 years experience in a validation, technical services, manufacturing operations, product development or related field in a pharmaceutical or biotechnology related industry PREFERRED
· Exposure to Technical Services/Product Development, Formulation, Process Validation and/or Cleaning Validation through pharmaceutical or biotechnology industry experience or academic practical studies REQUIRED
· Strong understanding and/or exposure in the operation of manufacturing equipment within production of solid and/or liquid oral dosage forms (tablet press, granulator, fluid bed processor etc.) REQUIRED
· Current working knowledge of cGMPs in the pharmaceutical industry REQUIRED
· Proficiency with Microsoft Office REQUIRED
· Excellent verbal and written communication and skills REQUIRED
· This is an office and manufacturing based position. Ability to wear Personal Protective Equipment (PPE) REQUIRED
· Proficiency in Visio and Minitab PREFERRED
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI