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Engineering
Full Time
5/27/2020
Houston, TX
Position Summary The Pharmaceutical Scientist performs finished product Research & Development (R&D). The Scientist executes R&D as related to product formulation from request to production, and develops and optimizes cycles for lyophilized products.
Duties and Responsibilities Performs product R&D as directed by Director of R&D. Products include, but are not limited to injectables, lyophilized products, tablets, capsules, creams, and suppositories Manages multiple product R&D on a timely basis to release product on-time as communicated with sales Validates lyophilized product from formulation to production lyophilized implementation Performs lyophilization process cycle development and optimization using an R&D lyophilizer Creates a validation report consisting of thermal characterization, cycle development, and production implementation Accountable for ensuring cGMP compliance of manufacturing operations to include operating procedures specifically related to the operation of the freeze dryers Evaluates production efficiencies, variances, and procedures within manufacturing on a continuous basis for process improvement Ensures batch documentation associated with lyophilization is of appropriate quality and is delivered in a timely fashion Leads investigation into deviations and identification and implementation of corrective actions related to product development Continuously audits/monitors documentation to detect undesirable trends or opportunities for improvements related to quality and/or efficiency

Benefits Health/Dental/Vision Flexible Spending Account (FSA) or Health Savings Accounts (HSA) 401(k) with company matching, no vesting period Paid holidays - 8 days Paid Vacation - 10 days
Position Type Full-time Monday - Friday
Full Time
5/27/2020
Houston, TX
Position Summary The Pharmaceutical Engineering Manager is responsible for leading a team in the development and implementation of production equipment and processes in order to provide a safe and efficient working environment, essential to the performance of the business.  This position reports to the Director of Facilities.
Duties and Responsibilities Develop and implement processes for the preventative maintenance program for manufacturing  equipment per standards in the industry and equipment manufactures’ recommendations.  Assist in developing schedule for and performing major engineering projects and facility modifications.  Coordinates maintenance shutdowns with the Director of Facilities to ensure the availability of resources for timely completion to maximize compounding capability.  Implements changes for improving manufacturing line efficiencies and maintenance performance.  Responsible for calibration program. Responsible for equipment qualification and validation (FAT/SAT/IQ/OQ/PQ protocol creation and/or execution). Interacts with and manages contractors for validation as required. Coordinates with material/equipment vendors as well. Performs quality investigations in a timely manner regarding deviations, out of tolerance conditions, unexpected results on facility issues by conducting failure analysis, root cause determination, and corrective action determination Drive continuous improvement by managing projects and recommending techniques to enhance equipment/system/process robustness. Leads change control processes related to equipment and facilities Works with manufacturing team for equipment operations training and implementation program. Write SOP’s, OSW’s, etc. to document processes. Assist with safety assessments for modifications to equipment. Develop and deliver ongoing training to staff regarding utilities equipment and hazards. Utilize facility engineering principles to solve straight forward problems. Work with production on a daily basis to coordinate appropriate course of action to maximize uptime and quality performance of respective area. Interface with Director of Facilities to complete requested engineering projects in a timely manner.
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