Engineering Qualification, Manager

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 :

Skills / Knowledge / Abilities :

Problem Solving :

TRAVEL REQUIREMENTS

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.