Manufacturing Automation Compliance Specialist Job

Description

Manufacturing Automation Compliance Specialist-MAN002865DescriptionMerck is a global health care leader with a diversified portfolio of prescription medicines, and vaccines, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.Position OverviewAt the Merck Manufacturing facility in Elkton, Virginia, we currently have a Manufacturing Automation Compliance Specialist Engineer position available.The successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of pharmaceutical product manufacturing facilities.Responsibilities Include:- Provide on-going compliance and System Development Life Cycle (SDLC) training to department personnel- Identify, interpret, and implement regulatory guidelines at the procedural level for SDLC Operation Phase Controls- Assess changes for validation requirements, including, but not limited to, document changes, process/equipment changes, and system changes- Collaborate with customers and stakeholders to generate, assess, and implement process improvements- Develop, implement, and maintain documentation standards- Support compliance auditsQualificationsEducation:* Required: BS degree in engineering, computer science, integrated technology, or science 2 years of relevant industry experienceRequired Experience:- Experience working with SDLC methodology- Experience implementing and maintaining validated hardware and software systems- Working knowledge of pharmaceutical regulatory agency requirements for automation and information systems- Experience working under cGMP- Experience managing projects- Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills.Preferred Experience:- Development and delivery of training programs- Change management- Management of people- Automation system administration- Computer validation coordinationOur employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.Search Firm Representatives - Please read carefully:Merck is not ...

Nr of positions available : 1