Validation Engineer
Job Description
**JOB DESCRIPTION**
**Position Title:** Validation Engineer I
**Department:** Validation
**Location:** Decatur, Illinois
**Employment Type:** Full-Time
**Position Summary:**
The Validation Engineer I will be responsible for overseeing all aspects of the validation process, ensuring that equipment, processes, and systems operate consistently and meet predetermined specifications. This includes documenting commissioning activities, establishing acceptance criteria, and conducting qualification studies for various equipment and processes, such as sterile injectable systems and cleaning procedures. The ideal candidate will work closely with cross-functional teams and manage multiple projects independently.
**Essential Duties & Responsibilities:**
* Schedule and plan equipment and process qualification activities to meet project deadlines.
* Write, execute, and review complex validation protocols (IQ/OQ/PQ/VQ).
* Coordinate validation activities with other departments to ensure seamless project execution.
* Operate and maintain thermal mapping equipment.
* Troubleshoot and resolve validation issues with minimal oversight, including conducting research as needed.
* Train and mentor junior validation personnel on validation procedures and protocols.
* Manage the site Change Control Program and ensure compliance with regulatory requirements.
* Purchase supplies and equipment required for validation activities.
**Required Qualifications:**
* **Education:** Bachelor’s degree in Chemistry, Engineering, Microbiology, or a related field from an accredited institution.
* **Experience:** Minimum of 3 years of experience in the pharmaceutical industry, with specific expertise in sterile injectable processes.
* Proven experience in validating equipment such as autoclaves, depyrogenation tunnels, stability chambers, incubators, refrigeration units, and analytical instruments.
* Knowledge and experience in validating cleaning processes, media fills, smoke studies, and Kaye instrumentation.
* Advanced knowledge of current Good Manufacturing Practices (cGMP) and regulatory requirements for IQ/OQ/PQ/VQ.
**Desired Skills & Competencies:**
* Ability to handle multiple projects simultaneously while meeting deadlines.
* Strong problem-solving skills and ability to work independently with little oversight.
* Excellent communication skills, both written and verbal, with the ability to train and mentor others.
* Ability to manage stressful situations, work off-hours or weekends when required, and meet attendance standards.
**Physical and Mental Requirements:**
* Ability to sit, stand, walk, and use hands to handle equipment.
* Close vision required for computer work and documentation.
* Exposure to machines, occasional chemicals, and solvents during validation activities.
* Ability to move and handle loaded carts with varying weights for validation purposes.
* Strong deductive reasoning, ability to understand complex issues, and maintain confidentiality when required.
**Additional Information:**
* **Work Authorization:** US Citizen, Green Card Holder, H1B Transfer, TN Visa (Canadian Citizens), OPT EAD holders welcome.
* **Benefits:** Full benefits package including medical, dental, vision insurance, 401K with 4% matching, PTO, paid holidays, health savings plans, life insurance, and more.
* **Relocation Expenses:** Considered on a case-by-case basis.
**Application Process:**
* **Initial Screening:** Phone interview via Microsoft Teams with Quality Control Leadership.
* **On-site Interview:** If within driving distance, an on-site interview will be scheduled. Candidates not in the area will have a remote interview, followed by an on-site visit before the offer.
Job Type: Full-time
Pay: Up to $75,000.00 per year
Benefits:
* 401(k)
* 401(k) matching
* Dental insurance
* Health insurance
* Life insurance
* Paid time off
* Vision insurance
Schedule:
* 8 hour shift
* Monday to Friday
Ability to Commute:
* Decatur, IL (Preferred)
Work Location: In person
