Principal/Sr/Specialist, MFG Performance Excellence and Planning, Fremont CA
$75k - $122kBoehringer Ingelheim GmbH
Principal/Sr/Specialist, MFG Performance Excellence and Planning, Fremont CA The Principal/Sr Specialist/Specialist, Manufacturing Performance Excellence and Planning will be responsible for managing in-depth short and long-term planning/forecasting in support of Manufacturing Operations (project based standard work packages, coordination of complex and in parallel preventative maintenance scheduling, production schedule debottlenecking options and opportunities, and site column strategy). This principal/Sr Specialist/specialist level role is a subject matter expert and will serve as the key liaison between production planning in Manufacturing and Supply Chain - combining the supply demands and information of the manufacturing planning team and other departments to facilitate maximum productivity of the facility. This role will ensure one or more of the following performance excellence elements are met: Monitoring performance of the three manufacturing trains (2K Drug Substance, 12K Drug Substance, Drug Product) by maintaining a KPI system throughout the organization. KPI's will be adaptive based on manufacturing operations requirements and will require a high level of cross functional collaboration. Based on gained insights for the established KPI's, this role will propose improvement initiatives to Senior Leadership. These KPIs are intended to drive multi-layer and cross functional actions to support business goals. Monitoring progress of strategic Train improvement or defined CAPEX projects to ensure progress or make roadblocks visible at the Manufacturing Leadership Team or cross-functional governance boards. Collaboration with improvement project leaders on paths forward to bring projects back on track. The Principal/Sr Specialist/Specialist position is responsible for utilizing expert level and critical understanding of manufacturing operations to lead or manage complex scheduling challenges that ensure business aligned timelines and commitments are met. The incumbent applies stakeholder management skills and scheduling proposals have significant business influence. This role will have direct communication with the Manufacturing Senior Leadership Team. Additional Information Compensation:This position offers a base salary typically between ($75,000 and $$122,000.00) or ($90,000 and $147,000) or ($115,000 and $181,000). There isopportunity 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. For an overview of our benefits pleaseclick here. Duties & Responsibilities Independently determines improvements to overall scheduling program and train effectiveness and drives improvement ideas to completion. Maintains a comprehensive, Key Performance Indicator platform which demonstrates actionable projects/actions for improvement and is aligned with the company’s overall goals and site strategy. Owns, maintains, and modifies scheduling systems (SchedulePro/EviView/etc.) on behalf of the manufacturing organization. This includes regular communication with system developers/engineers, system testing and issue troubleshooting to ensure the program fulfills manufacturing needs. Coaches/mentors junior staff members on robust scheduling techniques, communication strategies, and planning documentation (low to high complexity). Provides hands‑on training/guidance on scheduling topics, and reinforces production abilities/limitations to increase operational utilization. Key liaison between production planning in Manufacturing and Supply Chain - combining the supply demands and information of the manufacturing planning team and other departments to facilitate maximum productivity of the facility. Ensures that all KPI’s, metrics, and commitments are being managed and issues resolved in a timely manner to aide overall success for the group. Facilitates cross‑functional performance monitoring in the operations trains. Ensures that performance KPIs and expectations are set throughout the cross functional Operations team; makes performance and performance gaps visible to upper management. Proposes, aligns, and steers remediation activities (if applicable). Ensures train specific strategic projects will meet production deadlines. Represents Manufacturing in CAPEX/ project prioritization meetings cross functionally to confirm train priority and need. Updates/modifies sitewide project tracking tools for Manufacturing projects (if applicable). Designs, maintains, owns, and continuously improves the detailed short term and long‑term manufacturing schedule for multiple functional areas. Direct coordination with supply chain and business and contracts to agree on production schedule changes while identifying operational limitations. Executes scheduling solutions for the complex and continuously evolving production schedule . Sr Specialist Requirements Requirements Requires a High School Degree, with eight (8) years of experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility. OR Associate degree plus six (6) years of manufacturing experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility. OR Bachelor’s degree, preferably in a science or engineering related field plus three to four (3-4) years’ experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility. High level of understanding of MFG processes. Utilizes manufacturing experience and understands key technical details required to schedule operations. Experience leading meetings with a cross functional, mid leadership level audience. This role will lead mid complexity scheduling initiatives and participate in high complexity scheduling initiatives for Manufacturing. Significant scheduling experience and proven Project Management skills. Strong ability to communicate and strong presentation skills. Ability to understand data for organizational diagnosis and translate the gained insights into effective planning. Strong willingness to learn and apply various BPE/Lean/Six‑Sigma tools. Lean, efficiency and performance‑driven mindset. Technical: Knowledge around Biologics Manufacturing at a large biopharmaceutical company. Requirements: Specialist Requires a High School Degree, with six (6) years of experience in a cGMP pharmaceutical manufacturing environment. OR Associate degree plus four (4) years of manufacturing experience in a cGMP pharmaceutical manufacturing environment. OR Bachelor’s degree, preferably in a science or engineering related field plus two to three (2-3) years’ experience in a cGMP pharmaceutical manufacturing environment. Intermediate understanding of MFG processes. Understands and ability to interpret key technical details required to schedule operations. Experience leading meetings. This role will participate in mid complexity scheduling initiatives for Manufacturing. Experience working in the following platforms: MS Project, MS Excel, MS Visio, MS Word, MAXIMO and scheduling platforms. Experience with PowerBI preferred. Scheduling experience and Project Management skills. Strong ability to communicate with all levels in the organization. Requires an Associate degree, preferably in a science or engineering related field, plus eight to ten (8-10) years of manufacturing experience in a cGMP pharmaceutical environment with positions of progressive responsibility. OR Bachelor’s degree, preferably in a science or engineering related field, plus six to eight (6-8) years of manufacturing experience in a cGMP pharmaceutical environment with positions of progressive responsibility. OR Master’s degree, preferably in a science or engineering related field, plus four to six (4-6) years of manufacturing experience in a cGMP pharmaceutical environment with positions of progressive responsibility One (1) year of leadership/management experience preferred. Expert level of understanding of MFG processes Experience with short term and long‑term planning. Critical understanding on pharmaceutical processes so that planning is effective and has ability to deliver the site wide production plan Leadership/management experience required with demonstrated ability to set vision and direction for peer groups/cross functional teams Strong project management or change management experience in achieving results and managing others to achieve corporate, site, and departmental objectives. Experience leading meetings of large scope and size. This skill should be mastered. This role will lead large initiatives for Manufacturing. Outstanding communication, presentation and influencing skills to interact and gain the support of senior management at a site level. Ability to handle multiple parallel tasks and to provide the leadership through direct leadership as well as matrix leadership skills. Mastery in multi‑tasking. Extensive knowledge around Biologics Manufacturing at a large biopharmaceutical company. Eligibility Requirements : Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post‑offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities Additional Duties & Responsibilities : Implements corrective actions while engaging key stakeholders. Gains cross‑functional buy in/alignment for routine and non‑routine scheduling through meetings and strong stakeholder management skills. Steers and conducts cross‑functional meetings with maintenance schedulers, E&T teams, and CAPEX project managers to ensure routine and non‑routine planned events do not disrupt the operations schedule and to minimize impact of equipment downtime and maintenance work on productivity. This includes PM/CM/GM/CAPEX and Change Control activities. Focused on delivering products on‑time by identifying constraints and proposing scheduling modifications to relieve constraints. Creates alignment with all Quality cGMP compliance, process requirements, readiness, timeline, and revenue commitments, including asset availability to ensure schedule adherence and maximize efficiency and asset utilization. Ensures that all KPI’s, metrics, and commitments are being managed and issues resolved in a timely manner to aide overall success for the group. Maintains the site wide production plan within Manufacturing in the following ways: Subject Matter Expert (SME) for scheduling software and systems. Ability to work with the business owner, system owner and software representatives independently to resolve issues on behalf of manufacturing. Responsible for communication to key stakeholders and senior leadership. Schedules meetings to update schedules and incorporate non‑routine activities. This includes advanced levels of information sharing and interactions with all functional groups across BI Fremont, incorporating key inputs and for reporting outputs. Additional requirements : Must show executive presence. Demonstrated confidence presenting to Sr. Management. Experience presenting/speaking to auditors on a variety of topics of medium scope. Ability to understand complex data for organizational diagnosis and translate the gained insights into convincing solution proposals. Experience or strong willingness to learn and apply various BPE/Lean/Six‑Sigma tools. Lean, efficiency and performance‑driven mindset. #J-18808-Ljbffr Boehringer Ingelheim GmbH
$60 per hour
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