Engineer I -(Assistant) in West Point, PA at Integrated Resources, Inc

Date Posted: 2/14/2021

Job Snapshot

Job Description

Qualifications:
The ideal candidate would possess BS in Chemical, Biochemical, Biomedical engineering or a BS in the life sciences. Entry level resources w/1-3 years of experience in the pharmaceutical/regulated industry is preferred Direct or technical operations roles. Excellent oral and written communication skills with the ability to work independently and as part of a team, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies. Strong understanding/advanced knowledge of GMP/engineering documentation practices and design requirements for cGMP process. Familiar W/ Trackwise and or Change Control systems, multivariate data analysis tools, deviation management systems and process, CAPA investigations, batch record generation and review. Technology transfer experience a plus. Authoring/reviewing technical memo's and reports. 3+ years of experience writing change controls. Experience working with CMO's, project management skills/experience. Data focused - Data entry & data analysis. Phone/meeting/WebEx/Teams - Comfortable working remotely. 1 year to start - Will be extended. Should be local to West Point, however manager will consider remote work. About you You are organized, self-motivated and adaptable. You have a positive attitude, are attentive to every small detail and with that, have the ability to learn quickly. You are outgoing and not afraid to speak up, ask questions and share ideas; you are a data-focused collaborator!

Responsibilities:
Execute manufacturing process change controls as part of product lifecycle. Investigate manufacturing deviations to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented. Perform data monitoring and trending. Provide filing/submission support by source documentation mapping and data audits. Author reports/ technical documents as needed. Join calls with CMO's, data monitoring group, supporting team through campaign readiness, run business activities for commercial management manufacturing. Deviation management. There are approximately 10 people on the team who are very collaborative and work well together. The team is expanding. Work with cross functional teams to develop & improve manufacturing systems to support utilizing cGMP process equipment while maintaining and improving quality standards. Develop or revise technical related forms and documents for process and manufacturing equipment. Schedule and oversee the performance of preventive maintenance work orders of cGMP equipment. Implements corrective/preventive actions for existing equipment and manufacturing processes. Prepare change control documentation. Write and modify procedures for the proper operation of new and/or existing equipment. You will also manage external partnerships.