Sr. Validation Manager

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

Benefits offered by this job

Annual performance bonus

401(k) with company match

20 days PTO

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Validation Manager in Bedford, Ohio, to lead the Validation Master Plan and oversee qualification activities for equipment, facilities, and utilities in a cGMP environment.

You will review URS, IQ/OQ/PQ, and related documents, coordinate with Operations, Engineering, Quality Control and QA, and ensure all validation activities comply with regulatory standards and internal policies.

Qualifications

• 8-10 years of validation experience in the pharmaceutical or 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

Responsibilities

• Coordinate validation planning and scheduling with multiple departments.
• Review and approve URS, IQ, OQ, PQ, FAT, SAT, and related docs.
• Ensure CGMP compliance and proper documentation practices.
• Maintain and calibrate equipment used for qualification.
• Support change control and problem-solving to protect validated state.
• Oversee cross-functional coordination for validation projects.

Skills

Validation experience

GMP knowledge

Communication skills

Education

Bachelor's Degree in engineering or science

Tools

Microsoft Project

Trackwise

AMMS

Job description

Job Title

Sr. Validation Manager

Location

Bedford, Ohio

Job Type

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

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• 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.

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.