Teva Site Engineering Technology Expert - SLC West 

United States, Utah, Salt Lake City 

234144778

This position is responsible for the design, specification, acquisition, installation and qualification of manufacturing and/or packaging equipment associated with production of solid dose pharmaceutical products. This position will lead multi-disciplined teams to develop the requirements for needed capital equipment, manage the acquisition process, and lead the installation and qualification efforts on site. It is also responsible for troubleshooting complex systems, resolving the issues, identifying root causes of repeat issues and identifying opportunities for increasing equipment uptime, efficiency and throughput. The position ensures turnover of equipment to production in compliance with all regulatory requirements, company policies and site procedures.

• Responsible for developing project timelines and project costs based on input from end users as well as suppliers, then manages projects to meet established schedules and budgets.
• Responsible for establishing User Requirements and System Specifications for equipment used in the production of pharmaceutical products, according to SOPs.
• Responsible for soliciting and evaluating proposals from equipment vendors for purchase of equipment.
• Responsible for interfacing with relevant stakeholders/departments to lead the installation and qualification of new equipment and upgrades to existing equipment.
• Responsible for clear and effective communication.
• Responsible for assisting relevant stakeholders/departments in the development of new production areas.
• Responsible for investigation equipment performance and determining solutions.
• Responsible for contributing to and writing Qualification Protocols, SOPs and PMs in support of all new equipment and production processes.
• Responsible for performing and/or supporting the qualification of new and modified equipment.
• Responsible for troubleshooting electrical, mechanical, pneumatic, and hydraulic systems.
• Responsible for understanding equipment controls (PC, PLC and HMI) of new and existing manufacturing and packaging equipment.
• Responsible for writing and execution of change controls for new and existing equipment.
• Responsible for directing or overseeing the work of junior personnel as needed.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.
  

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Requires Bachelor’s Degree in Engineering, Scientific or Technical field and a minimum of 7 years relevant progressive experience, preferably in a manufacturing environment within pharmaceutical, medical device or nutraceutical industries.
• Prefer knowledge in mechanical design software such as SolidWorks and/or AutoCAD, and familiarity with machine controls and machine controls software
• Requires experience with and understanding of equipment controls, troubleshooting of machine systems and the installation, qualification and ongoing support of production equipment.
• Prefer solid oral dose and granulation equipment and process experience.

Skills/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products and other position-related applications, such as SAP, Oracle, TrackWise and other computer relational databases.
• Detail oriented with ability analyze information, create metrics and articulate the link to business needs/objectives.
• Interact positively and collaborate with co-workers, management and external partners.
• Detailed knowledge and experience with change control and applicable qualification and validation processes.
• Ability to work in a team environment through conflict resolution and negotiations, influence and lead others with and/or without direct supervisory authority.
• Self-directed with ability to organize and prioritize work.
• Communicate effectively with strong written and oral communication and technical writing skills.
• Familiarity with engineering design principles as related to validation.
• Project management skills.
• Subject matter expert on granulation equipment and process.

Problem Solving:

• Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining problem resolutions.
• Acts independently and proactively to determine and administer methods and procedures for problem resolution.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

Associate Director, Engineering

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