Successful candidate will possess a minimum of a bachelor's degree in an Engineering field with at least 2 years of experience working in the pharmaceutical industry, preferably in the biotechnology sector.
A successful candidate will have knowledge and experience with MES technologies.
Syncade and DeltaV would be preferable.
MS Windows Server and SQL server also a plus.
Demonstrated experience working in diverse, multi-disciplined work groups.
Experience and/or substantial understanding of process control principles and common system vendors' available products.
Skills in ISA88 batch, historian technology, databases, and reporting systems.
Ability to work in a diverse work environment, manage multiple priorities, and at times, be self-directed.
Excellent written and communication skill are required.
Candidate must have a flexible and creative work style with a goal of attaining excellence.
Provide central support for site integrated manufacturing execution platform. Assure reliable 24/7 operation of integrated manufacturing systems.
Develop methods for maintaining and documenting adherence to company policies and procedures for manufacturing and information systems.
Maintain a MES support strategy that integrates process knowledge, equipment design, and quality standards with information technology to reduce down-time, elevate the level of regulatory compliance, and introduce efficiency gains through effective use of available technologies.
Implement manufacturing information and reporting systems that support the creation of paperless batch records and facilitate product release.
Responsible for authoring recipe (simple to moderate changes) using Functional specification provided by Manufacturing Lead in Syncade system.
Ability to troubleshoot the recipe as well.
Work closely with the Enterprise and Vendor to provide support in the evaluation and implementation of MES application upgrades, hotfixes etc.
Monitor systems performance and review logs and diagnostic information and respond appropriately.
Understand the manufacturing processes and system configuration and make informed recommendations regarding optimal system configuration.
Support software and configuration required for external systems interfaces such as DeltaV, SAP, LIMS, PI, and Maximo.
Provide support for deviation assessment, RCA for process or automation related events that can lead to CAPA (Corrective Action and Preventive Action). Act as Lead for Low and Medium risk investigation.
Strong Technical writing skills for updating SOPs, WI, Knowledgebase articles etc.
Provide on-call support for Syncade system on as required basis.
Work with all departments and with all levels of the organization, specifically Quality, Manufacturing Engineering, and Manufacturing Operations.
Work within all Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE).
Although this is primarily a day shift position, support of 24/7 manufacturing operations will require off shift coverage (nights and weekends), potentially for extended periods of time.
Position also requires availability to be " on call off shift hours, based on a rotating schedule, to support manufacturing operations.
This is a full-time direct hire position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Kevin: kevin@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00394
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE