Bayer Manufacturing Automation Systems Lifecycle Specialist in Berkeley, CA, California
Your tasks and responsibilities
Bayer seeks high energy leaders ready to help shape the future by confronting new challenges, embracing new experiences and taking on increasing responsibilities. Ensures Manufacturing Automation Systems (non-engineering Mfg IT systems) operate in a compliant and efficient manner.
More specifically related to this role, the incumbent will have responsibilities to include, but not limited to:
This position is responsible for:
•Serves as System Owner representative and project manager on behalf of BHC Berkeley manufacturing to ensure MAS operates in a compliant and efficient manner. Partners with multiple organizations onsite as customer and/or service provider. • Establishes procedures and standards related to the support and operation of the MAS systems. Monitors system and system support performance for error correction, and enhancement opportunities. • Supports changes to MAS environment, including system fixes, enhancements, Global configuration/master data changes, Deviation and CAPA management. • Performs routine system ownership activities on MAS systems, including system reviews, user/role reviews, user authorization and others required by standards or compliance requirements. • Reviews, evaluates and updates or enhances the infrastructure and supporting technical environment for MAS in conjunction with BHC and BBTS. • Defines, creates and maintains compliant procedures and documentation for administering and supporting MAS in collaboration with system owners for integrated systems from other functions such as Engineering and Quality Control, Administrative and support organizations in BHC, BBTS, Validation and Quality Computer System organizations within BHC, BBTS. • Supports the definition and creation of technical solutions and operational procedures for MAS in collaboration with the above listed organizations and end user communities within BHC. • Maintains validation documentation, practices and processes for each MAS in compliance with site SOPs, company directives and regulatory expectations. • Collects and analyzes support-related Key Production Indicators (KPIs) on multiple Manufacturing IT Systems with the intent to identify compliance, security or technical issues to the existing systems, maintains a high quality of service from MAS administrative teams, discover opportunities for improvement in systems and their support processes.
Who you are
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, and Efficiency) values. Related to this position, we are seeking an incumbent who possess the following:
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:
Minimum Education BS/BA/MS in IT, Engineering or Manufacturing related field BS/BA with 5+ years industry experience OR MS with 2-4+ years industry experience PMP or other professional certification a plus. Minimum experience or an equivalent combination of education and experience required. Experience in pharmaceuticals or other regulated industry with emphasis on software, business process development, system administration/validation and/or compliance management.
• Ability to work with and sometimes lead cross-functional, matrix managed teams that deliver sustainable processes and solutions for Manufacturing Automation Systems. • Good experience with one or more of the following system categories is desired, certification is a plus: ERP, MES, DCS/SCADA, LIMS/MODA, Discoverant. • Knowledge of FDA regulations 21 CFR Parts, 11, 210, 211, 820, cGMP standards, GAMP standards • Good technical writing and communication skills. • Good organizational skills. • Ability to work in a self-directed manner.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. . To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled