Sr. Manager, Validation

RXinsider LTD.; Bedford (OH); On-site; USD 93,000 - 158,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

20 days PTO

3 personal days per year

11 company holidays

Health insurance

Dental & vision coverage

Disability & life insurance

Employee discounts

Wellbeing program

Career growth opportunities

Tuition reimbursement

Paid maternity and parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, OH, is seeking a Sr. Validation Manager to lead validation activities for CGMP-compliant processes and equipment. You will manage VMPs, IQ/OQ/PQ, URS review, and cross-functional coordination across Operations, Engineering, Quality Control and Quality Assurance.

The role requires 8–10 years’ validation experience in pharma, a technical degree, plus strong documentation and problem-solving skills. A robust benefits package is offered.

Qualifications

• 8-10 years of validation experience in the pharmaceutical or GMP industry.
• Bachelor’s Degree in engineering, science or related discipline.
• Experience with aseptic processes preferred.
• Knowledge of Microsoft Project, TrackWise and AMMS preferred.
• Demonstrated ability to communicate effectively.

Responsibilities

• Coordinate validation planning, scheduling and resource needs across departments.
• Review and approve URS, IQ, OQ, PQ, FAT, SAT documents.
• Support change control processes and investigation of deviations.
• Ensure CGMP and regulatory compliance (21 CFR parts 210/211).
• Guide equipment qualification and related documentation activities.

Job description

Sr. Validation Manager

Bedford, Ohio

Full-time

About Us

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Validation Manager to join our team. In this role, you will be responsible for the Validation Master Plan (VMP) and managing qualifications and re-qualifications. This includes the review and approval of validation protocols, reports, and related documentation such as: User Requirements Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), as well as Re-qualification (RQ) of process equipment, facility equipment and utility systems. Responsibility encompasses completion of validation activities that meet the requirements of the cGMP's as well as the pharmaceutical industry standards and comply with site validation policy.

Key Responsibilities

• Coordinate and maintain critical validation responsibilities such as planning, scheduling, identifying resource requirements (people and equipment), coordinating with other departments, and ensuring compliance with applicable VMPs.
• Provides input to, reviews and approves User Requirements Specifications (URS).
• Review and approves protocols including Cycle Development Protocols, Investigational/Engineering Study Protocols, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
• Provides input to Engineering on the preparation and execution of Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and Commissioning protocols.
• Researches equipment and processes, and establishes parameters and methods to test equipment to meet validation requirements.
• Ensures an effective coordination of the execution of qualifications and all aspects of the validation project with other departments, including but not limited to: Operations, Engineering, Quality Control and Quality Assurance.
• Ensures that the execution of protocols and all related documentation is in compliance with current Good Documentation Practices.
• Ensures equipment used for qualification purposes is properly maintained and calibrated.
• Supports and participates in change control process for critical system/equipment updates and repairs performed through the Work Order control mechanisms. Fully understands the requirements of each change control procedure.
• Assists in equipment troubleshooting and the use of problem solving techniques to resolve issues that could impact the validated state of equipment.
• Performs other duties as assigned and required.
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Qualifications

• 8-10 years of validation experience in the pharmaceutical or other GMP-regulated industry
• Experience with aseptic processes is preferred
• Bachelor’s Degree in engineering, science or another discipline with equivalent work experience
• Knowledge of Microsoft Project, Trackwise, AMMS preferred
• Demonstrated ability to communicate effectively with others

Compensation

Base Salary: $92,850.00 to $158,450.00 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 4% 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.