Manager, Equipment & Engineering - 2904

We Are Teva

Our Team, Your Impact

We are seeking an Engineering Qualification, Manager to lead project management, commissioning, and qualification activities for facilities, utilities, and computer systems. Responsibilities include developing and executing project plan, qualification documentation, ensuring compliance with GMP and industry standards, and mentoring team members.

How You’ll Spend Your Day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.  

•    Fulfills responsibilities according to organizational policies, procedures, and applicable state, federal, and local laws.
•    Reviews manufacturer and blueprint specifications for electrical, mechanical, and software/computer systems to identify critical parameters.
•    Prepares Qualification Project Plans and protocols (IQ/OQ/PQ) that test the critical parameters relevant to installation, operation, and performance for facilities, utilities, computer systems, or equipment.
•    Ensures protocols receive approval through appropriate channels; drafts and updates validation protocols as needed.
•    Executes validation and qualification protocols following relevant SOPs and verifies that acceptance criteria are satisfied.
•    Records all test data in compliance with cGMP requirements.
•    Prepares final reports and ensures proper approval.
•    Develops and communicates project timelines and status updates.
•    Adheres to GMP and safety requirements, SOPs, and company policies and procedures.
•    Completes related duties as assigned.
•    Conducts periodic reviews of equipment and system qualifications, prepares summary reports, and manages CAPAs for any identified deficiencies. This includes reviewing change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS where applicable.
•    Prepares or updates Site Validation Master Plans.
•    Develops and applies FMEAs, RCAs, and other investigative tools for failures and investigations.
•    Conducts risk assessments associated with qualification activities, change management processes, or quality investigations.
•    Possesses technical knowledge of computerized systems/equipment, preferably in solid oral dosage manufacturing, facilities, and utilities.
•    Has familiarity with GAMP and CFR 21 Part 11 requirements.
•    Demonstrates effective oral and written communication skills in English.
•    Works independently with limited supervision.
•    Capable of writing protocol deviations and identifying root causes and corrective actions

Your Skills and Experience

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

Education/Certification/Experience:
•    Bachelors in Engineering required (Chemical or Mechanical)
•    Master’s in Engineering Preferred(Chemical or Mechanical) and Project Management
•    5-7 years of experience within pharmaceutical or related manufacturing facility.
•    Preferred previous experience in a manufacturing environment within pharmaceutical industries.
•    Experience in development and execution of qualification protocol/reports as related to automated equipment/systems and computer systems preferred.

Skills/Knowledge/Abilities:
•    Strong technical expertise in computerized systems, automation, and digital analytics.
•    Proficiency in Power BI, Excel, Python, and other digital tools for data management and analysis.
•    Knowledge of GMP, GAMP guidelines, CFR 21 Part 11 compliance, EMA, ANVISA, HC, PRC, PIC, etc. and risk management related to computer systems.
•    Ability to write clear protocols, manage deviations, and communicate findings effectively.
•    Concise and organized writing of technical data.
•    Works with multiple departments to gather and summarize findings.
•    Understands manufacturing equipment functional parts including control systems, mechanical components, and electrical power.