Manager, Equipment & Engineering

Role Overview

• Lead project management, commissioning, and qualification activities for facilities, utilities, and computer systems.
• Develop and execute project plan, qualification documentation, ensuring compliance with GMP and industry standards.
• Mentor team members.
• 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.
• 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.
• 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.

Requirements

• 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.
• 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.

Tech Stack

• Python

Benefits

• 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.