- 8 years of GMP experience (no less), doing maintenance management in the pharmaceutical industry.
- Candidates must be on the maintenance manufacturing side
- Must have expereince supporting 24/7 operations
- Bachelor's degree or equivalent combination of education and experience.
- A minimum of eight (8) years of manufacturing equipment maintenance experience with increasing levels of responsibility and authority.
- Process engineering and analytical process mapping experience required.
- Experience using CMMS system (Maximo, BMRAM, etc.) required.
- Experienced working with systems: Purified Water, HVAC, Steam, Compressed air and Chilled water systems in addition to equipment like: reactors, mixers, centrifugal pumps, Centrifuges, etc.
- Experience implementing RCM and TPM maintenance approaches
- Manage direct reports and provide leadership and guidance for their professional and personal development.
- Hands on experience with AUTOCAD software.
- Experience in the biotech and/or pharmaceutical manufacturing industry preferred.
- Experience working in a 24-hour production facility or critical utility environment preferred.
- Hazard Analysis and Critical Control Points (HACCP) certification strongly preferred.
- Achieve sustainability goals around utilities, water, power, and solid waste.
- Ensure information flow, employee development, problem-solving, goal setting, performance evaluation, and process improvements by coaching, empowering, and supporting the engineering maintenance departments in a High Performance Work System (HPWS) environment.
- Assess and build technical capability of site employees across functions and levels.
- Develop, administer, and manage an operating budget for the Maintenance Department.
- Accountable for the development and implementation of effective preventive maintenance programs, along with the establishment of a proficient maintenance stores procurement and inventory control system, as applicable.
- Evaluate, monitor, and upgrade equipment PM strategy that result in a continuous reduction of MTBF and MTTR and increase an equipment/system uptime.
- Apply best practices and technology aligned with the biological development and manufacturing of product.
- Maintain the plant infrastructure.
- Coordinate the selection, design and layout of biological manufacturing equipment, and control systems to ensure efficiency & reliability.
- Initiate design changes and modifications to improve Process Reliability, meet cost reduction goals and reduce dependencies on manual labor on an on-going basis.
- Provide continuous leadership and guidance to maintenance, facility and utilities engineering personnel.
- Review operations and confer with technical or administrative staff to resolve equipment or processing problems.
- Develop positive partnerships with other operational functions (i.e. production or human resources) and suppliers to ensure human capital, equipment, production and sanitation processes are used in the most effective/efficient manner to meet or exceed manufacturing targets.
- Own and drive safety programs to ensure operations personnel are in compliance with federal/state and company policies and procedures.
- Meet with vendors and suppliers to learn about and evaluate products used in repair work.
- Compute estimates and actual costs of factors such as materials, labor, and outside contractors.
- Review, evaluate, accept, and coordinate completion of work bid from contractors.
- Interpret specifications, blueprints, and job orders to construct templates and lay out reference points for workers.
- Design input into equipment specification and design for maintainability and standarization.
- Recommend and/or manage continuous improvement in a way that engages employees and functional partners in systematic, effective and collaborative manner.
- Cooperate with managers and other leaders to ensure all Company legal and ethical requirements are met.
- Drive EHS and GMP compliance to ensure a successful compliance/safety culture.
- Participate in emergency and crisis management teams.
- Ensure all aspects of plant KPI'S are being reviewed and communicated to operations team and recommend ways to improve.
- Manage the Maintenance Training Program and conduct training to maintain compliance with Company and regulatory requirements.
- Drive Safety with supervisors and managers to ensure compliance with all Company policies, Standard Operating Procedures (SOP), Injury and Illness Prevention Program (IIPP), Hazard Communication, and Good Manufacturing Practices (GMP) as outlined in the Code of Federal Regulations, Title 21 - Section
- Assist with the management of budget, expenses and P&L responsibilities effectively.
- Perform physical activities as outlined in the attached Physical Demands section of this position description.
- Adaptable to a fast paced, shifting work environment, willing to remain flexible to accommodate changing business conditions, work requirements and scheduling needs.
- Generate QA investigations and perform Root Cause Analysis to prevent recurrence.
- Strong analytical, problem solving and project management skills.
- Ability to write reports, business correspondence and standard operating procedures.
- Computer Skills / Special Equipment Knowledge: Computer skills – Microsoft Office skills (Excel, Word, Outlook).
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Senior Engineering Manager - Bothell, United States - Planet Pharma
Description
Location: 100% onsite in Bothell, Washington - Relocation package, TN Visa (Canada) accepted
Pay: $143k - $195k
Perks: 4 weeks of PTO
MUST HAVE:
A Life Science company in the Pacific Northwest is looking to add Sr. Manager, Engineering Maintenance to their team. This position will be accountable for all equipment maintenance & sustainability, managing internal resources and working with external vendors and consultants as needed. Additional duties include reliability, cost & waste reduction, sustainability, quality and equipment sanitation improvements, downtime reduction, cost improvement project implementation, as well as ensuring compliance with SOP's. Individuals interested in this role must have prior experience developing appropriate maintenance structure, work systems, Key Performance Indicators (KPI), and people capabilities to maximize equipment uptime, efficiency, and throughput.
Required skills:
Preferred skills:
Responsibilities:
Additional duties as assigned:
