Specialist, MES MBR Designer, Fremont CA

Description

This position offers a base salary typically between (75,000) and (122,000).  There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. 

Responsible for understand all the complexities of the BioMES system, lead the design of new types electronic batch record recipes, mentor junior staff on trouble shooting efforts within the BioMES system and managing and owning continuous improvement initiatives relative to BioMES. This position is also responsible for the overall business process and improvement topics relative to electronic records. This position is expected to understand the nuances of the highly complicated electronic system. This position utilizes LEAN tools to systematically evaluate information flow, create project plans and drive right first time success. The Specialist trains junior modelers to learn how to generate batch records, generates and refines batch record creation training materials, and develops the trouble shooting skills of the team. The specialist works with client groups (Process Engineers, Operations, Quality) to determine improvement opportunities within the scope of electronic batch records and leads the team to prioritize and implement said improvements. This role is required to work with industry experts to stay abreast of industry changes and expectations related to computer systems and electronic batch record design and to influence changes to software such that it continues to meet the needs of the business. This role requires a small amount of travel (1-2 trips/ year) The Specialist leads improvement teams, participates in project teams and works within BioPharma BioMES team to standardize business processes. The person within this role is the business process owner for BioMES business processes such as templates, review, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• BioMES expert. Mentors modelers to learn and troubleshoot challenges within BioMES system.
• Trains new modelers to develop GMP, consistent and streamlined batch records in BioMES. Leads team to create new batch record types and systematically evaluate information requirements.
• Leads cross functional Fremont team to identify and implement business process improvements. This is realized through project management skills and cross functional team leadership.
• Actively participate in the identification and implementation of manufacturing procedure improvements intended to optimize existing processes and ensure achievement of regulatory and safety requirements. Update GMP documentation as required.
• Participate in BioMES user group meetings and bring influence software company (Werum) to address software improvements.
• Standardize business processes across BioPharma. Local business process owner for BioMES business processes such as batch record templates, review processes, content requirements for batch records, etc.
• Actively participate in troubleshooting and variable identification for specific processes or activities as assigned.
• Assist IT to maintain a compliant, qualified and healthy MES system through systematic resolution of issues and communication with Werum to resolve system bugs.

Requirements

• Requires a Bachelor’s degree from an accredited institution, preferably in a related field plus a minimum of four (4) to six (6) years’ experience in a GMP Pharmaceutical manufacturing environment.
• In lieu of a Bachelor's degree, will consider an Associate's degree from an accredited institution, in a related field with a minimum of ten (10) years’ experience in a GMP Pharmaceutical manufacturing environment.
• In lieu of a Bachelor's or Associate's degree, will consider a High school diploma/GED plus (12) years’ experience in a GMP in a Pharmaceutical manufacturing environment.
• BioMES system expert
• Drives continuous process improvements for BioMES batch record processes business processes.
• Developing leader, able to technically understand complex manufacturing execution system.
• Ability to transform/translate process information/design from process description into a BioMES Master Batch Record
• Strong independent judgment and decision making abilities required.
• Strong knowledge of relevant regulatory guidances.
• Demonstrated problem-detection and problem-resolution skills required.
• Strong conflict resolution and negotiation skills required.
• Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
• Must possess excellent verbal and written communication skills; good interpersonal skills.
• IT experience preferred
• Strong leadership skills
• Strong ability to communicate
• Strong ability to influence in a team environment and collaborate with peers.
• To be qualified for this position must meet the following:
• Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking, eyestrain, etc. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
• Visual Demands - Position requires constant use of computer terminals and routine / repetitive work.
• Temperaments/Mental Requirements - The position requires concentration as errors might cause moderate to serious delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
• Level of Proficiency - Experienced level subject matter proficiency required
• Attendance / Schedule - The schedule is dependent on the shift hired. Attendance requirements are based on general attendance policies.
• To remain in this position, employees:
• Must obtain ' maintain qualifications, as required, to perform the assigned work.
• Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
• Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’s
• Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time.

Desired Skills, Experience and Abilities

• Experience with manufacturing execution systems (electronic batch records). Experience working in multiple projects.
• minimum of one year MBR Designer experience preferred 
• Project Management and/or Lean Six Sigma skills highly desired