Senior Validation Engineer - Pharma Equipment & Processes

RXinsider LTD.; Bedford (OH); On-site; USD 60,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

20 PTO days

Health insurance

Tuition reimbursement

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Validation Engineer to support parenteral manufacturing by validating equipment, materials and processes.

You will author protocols, reports, and change controls, and coordinate with production, planning, testing labs to ensure compliance with cGXP and regulatory expectations. You will lead validation projects, mentor junior staff, and collaborate with facilities engineering for installation and commissioning.

Qualifications

• BS preferably in the Sciences/Engineering/Math with minimum 4+ years related experience
• Other degrees accepted provided the individual has relevant experience in sciences or validations
• Ability to communicate effectively at all levels in verbal and written form
• Ability to walk 1-3 miles, stand 3-6 hours, and lift 10-40 lbs as required
• Ability to work any shift (1st-3rd) and any day of the week (7 days) as duties require

Responsibilities

• Leads on new equipment validation; writes protocols and reports and executes Change Controls coordinating with Production, Planning, Testing Labs, etc.
• Applies cGXP knowledge and project procedures to validations and related studies
• Performs projects in Equipment Validation and Manufacturing Operations support
• Serves as project lead with cross-functional teams; collaborates with facilities engineering for installation and commissioning
• Mentors and provides leadership to junior team members

Skills

Communication

Independent work

Physical stamina

Shift flexibility

Education

BS in Sciences/Engineering/Math

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Validation Engineer to support parenteral manufacturing by validating equipment, materials and processes.

You will author protocols, reports, and change controls, and coordinate with production, planning, testing labs to ensure compliance with cGXP and regulatory expectations. You will lead validation projects, mentor junior staff, and collaborate with facilities engineering for installation and commissioning.