Engineering Qualification, Manager

Who we are

The opportunity

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 experience and qualifications

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.  
•    Interpreting software changes, diagrams and flowcharts, design drawings (blue prints) and/or construction drawings and specifications including but not limited to HVAC, CA, Water Systems.
•    Communicating clearly and concisely, both orally and in writing. 
•    Strong technical writing skills.
•    Pharmaceutical principles, practices and applications.
•    Principles and practices of qualification and validation.
•    Techniques and principles of sampling, testing and measuring of mathematical calculations.
•    Mechanical and electrical concepts.
•    Ensuring compliance with all company policies and procedures, including safety rules and regulations.

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 support and resources when selecting methods and techniques for obtaining problem resolutions.

TRAVEL REQUIREMENTS

•    N/A

Enjoy a more rewarding choice

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 and holidays. 

Life and Disability Protection: Company paid Life and Disability insurance. 

Additional benefits include, but are 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.  

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.   

Reports To

Associate Director, Site Engineering

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.