Sr. Validation Engineer

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

Job Title: Sr. Validation Engineer

This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment, raw materials, and manufacturing processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.

Essential Duties and Responsibilities:

• Takes lead role on new equipment validation. Writes protocols, reports (GTRs), Site and Master Batch Record Change Controls and Executes protocols that involves coordination with many functional areas including Production, Planning, Testing Laboratories, etc.
• Applies cGXPs knowledge, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Performs a variety of projects/studies in areas that include Equipment Validation, as well as projects/studies to support Manufacturing Operations.
• Serves as project lead with projects of extended scope and cross-functional teams. Works closely with facilities engineering for equipment implementation, installation, and commissioning.
• Mentors and provides leadership to junior team members.

Qualifications:

• Ability to communicate effectively at all levels in verbal and written form.
• Direct or indirect industry knowledge and the ability to learn new technical information and concepts.
• Ability to work independently or in teams.
• Ability to walk some distance 1-3 miles, stand for 3-6 hours and periodically lift 10 - 40 lbs during the course of a work day as required.
• Ability to work any shift (1st, 2nd or 3rd) and any day of the week (7 days) as duties require.

Education and/or Experience:

• BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience -- e.g. education or employment in sciences or validations) having a minimum of 4+ years related experience or 3+ years related experience w/ an advanced degree or demonstrated performance within a technical department within the organization.

Compensation:

Base Salary: $59,900.00 to $120,450 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.