Overview

STA Pharmaceutical US LLC, a WuXi AppTec Company, is a contract development and manufacturing organization focused on providing high-quality process development, R&D, GLP Tox lots and up to P1/ P2 GMP small molecule manufacturing services to the biopharmaceutical industry.

The Process Engineer II prepares GMP documentation such as batch/cleaning records, equipment qualification protocols, campaign reports, etc. for the Pilot Plant and Kilo Lab with minimal oversight from supervisor/management. Prepares QA documents such as SOPs/TWIs to ensure cGMP compliance, also with minimal oversight. Evaluates and improves current procedures and equipment in the Pilot Plant. Interacts with QA, QC, Process R&D, Materials Management, EH&S, Facilities, and Purchasing to optimize and execute manufacturing campaigns. Assists with the execution of GMP and non-GMP production in the Pilot Plant and Kilo Lab and consistently reviews batch records to make sure that information is represented accurately. Performs safety testing (DSC, RC-1, TSU, etc.) and other tests to collect and analyze data for project support. Interacts with clients regularly during team meetings and puts together project weekly updates and daily production updates.

Responsibilities

Essential Job Functions:

• Prepares GMP and proprietary documentation (ie. batch/cleaning records, equipment qualification, campaign reports, etc.) for the Pilot Plant and Kilo Lab with minimal oversight from supervisor/management. During execution of batch/cleaning records or equipment qualification, consistently reviews the documents with the production team to make sure the information is represented accurately.
• Prepares calculations based on R&D reports in writing project documentation.
• Requests materials to be purchased for production projects.
• Prepares QA documentation such as SOPs and TWIs to ensure cGMP compliance of processes and associated equipment in the Pilot Plant and Kilo Lab, also with minimal oversight.
• Evaluates current procedures and equipment in the Pilot Plant and Kilo Lab for continuous improvement.
• Participates in the evaluation for new production/engineering equipment and responsible to prepare necessary documentation (URS, IA, TWI, Qualification Protocol, etc.).
• Interacts with Quality Control, Quality Assurance, Materials Management, Facilities, Process R&D, EH&S, and Purchasing in an effective manner to optimize and execute GMP and non-GMP manufacturing campaigns.
• Interacts with clients regularly during team meetings (leading meetings if requested) and puts together project weekly updates and daily production updates. May be called upon as SME during client/regulatory audits.
• Interaction with vendors for Pilot Plant and Kilo Lab equipment as needed for purchasing new equipment, planning maintenance and calibration, etc.
• Participates in the execution of chemical processes in the Pilot Plant and Kilo Lab. Assists in routine operations for cleaning, CIP, solution preparation, and charging.
• Performs safety testing (DSC, RC-1, TSU, etc.), analyzes data to assess process safety, and prepares process safety reports for GMP and non-GMP projects.
• Assists with structural characterization of solid materials for GMP and non-GMP projects (PXRD, polarizing microscope, etc.) as needed.
• Assists process chemists with lab work as needed.
• Assists training new members of the Engineering team as needed.
• Additional duties as assigned.

Qualifications

Job Requirements:

• Bachelor’s degree or higher in Chemical Engineering or a related discipline.
• Previous handling of chemicals preferred.
• 2-4 years of relevant experience preferred.
• Must be able to use and maintain large-scale Pilot Plant equipment and portable Kilo Lab equipment, with sufficient training (provided) within 6-12 months of hire. 
• Must be able to understand pharmaceutical production and testing/quality management with sufficient training (provided) within 6-12 months of hire.
• Must be able to learn and follow GMP regulations.
• Must be organized and able to work on multiple projects.
• Must be skilled with a computer (MS Office suite).
• Ability to learn chemical processing and/or process safety.
• Must be medically fit to wear a respirator, lift 50 pounds, and be comfortable working with, and around hazardous materials.

WuXi AppTec requires all employees, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine by February 9, 2022 or undergo weekly COVID-19 testing as set forth in WuXi AppTec’s Mandatory COVID-19 Vaccination Policy, unless they are eligible for an exemption from the vaccination or testing requirements based on a disability or sincerely held religious belief, practice or observance. If you are offered employment with WuXi AppTec, you will be required to provide acceptable proof of your COVID-19 vaccine (if applicable) no later than 8 days before your first day of employment.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.