Position Name: IT Services - MES Engineer Location: Bothell, WA 98021 (Onsite) Duration: 12 Months Type: W2 contract
Top Skills:
Experience with Emerson Syncade MES and 21CFR Part 11 or other GMP validation setting,
This includes authoring and executing validation protocols and software development lifecycle management.
Experience with HTML, XML, VBScript, SQL, or other programming languages accepted.
Self-starter and driven to find solutions.
Strong ability to work independently and manage their projects/tasks.
Purpose and Scope of Position (Position Summary): The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration and validation in the Emerson Syncade Manufacturing Execution System (MES). This role will support new product and process deployments as well as EBR revisions within the MES space in conjunction with several cross-functional departments.
Qualification Requirements (Knowledge, Skills, and Abilities): Education: • Bachelor’s degree or equivalent experience.
Experience: • 5+ years in computer or science-based field • Direct experience in Emerson Syncade MES System. Experience in another MES system will be considered. • Experience with writing and executing validation protocols. • Strong technical writing competency and GMP procedure writing. • Strong interpersonal skills to work with teams in different functions and organizations.
Preferred Qualifications: • Experience with SQL and XML coding in a MES construct. MS Windows Server and SQL server also a plus. • Experience with cell therapy or other biopharmaceutical manufacturing. Other highly regulated industries will be considered. • Flexibility to work within manufacturing schedules. • Experience with BarTender label development. • Experience with MES-ERP integrations. • Experience with new process and product deployments within a MES.
Roles and Responsibilities: • Collaborate with Manufacturing, Supply Chain, Quality, Facilities and Tech Transfer departments, capturing and documenting detailed requirements • Perform application support duties for the manufacturing execution system (MES) as needed • Develop standards and best practices for development and validation activities • Lead cross-functional teams through design reviews and user acceptance testing during the development and validation process. • Perform and communicate planning, development, peer review, and testing solutions for recipe creation and modification • Execute development and implementation of new capabilities across the Manufacturing systems based on requirements, specifications, and developed software solutions • Develop MES solutions including recipe, configuration and/or system changes to meet business requirements • Create and execute system test and/or operational qualification scripts to challenge the business and technical requirements • Participate in facility operational meetings to ensure facility reporting needs are met • Provide mentorship and training for new MES recipe developers • Assure quality customer service to all customers • Position also requires availability to be “on call” off shift hours, based on a rotating schedule, to support manufacturing operations
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $70.00/daily.
