Validation Engineer at Nephron Pharmaceuticals in West Columbia, South Carolina

Job Description:

Corporate Statement

Nephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. Nephron is currently working on research and development projects that include over 50 new products. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone.

Position Summary:

• Coordinate, perform and oversee qualification and validation activities.

• Contribute directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols, change controls and reports for the facility.

• Assists with additional work duties or responsibilities as evident or required.

• Performs other duties as assigned or apparent.

Primary Accountabilities:

• Write installation, operational and performance qualification protocols for production equipment, laboratories (Micro & Chemist) and process validation for production processes as required and based on experience. Write new Standard Operating Procedures for department use.

• Execute and/or coordinate execution of validation protocols with R&D engineers, engineering personnel, quality assurance, production personnel and/or (Micro & Chemist) laboratories. Write summary reports for the completed qualifications including recommendations for process improvements.

• Analyze validation test data to determine whether systems or processes have met validation criteria.

• Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products.

• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.

• Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.

• Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.

• Prepare, maintain, or review validation and compliance documentation, such as change control records, schematics, or protocols.

• Resolve testing problems by modifying testing methods or revising test objectives and standards.

• Prepare detailed reports based on results of validation and qualification tests or reviews of procedures and protocols.

• Identify deviations from established product or process standards and provide recommendations for resolving deviations.

• Perform statistical analysis.

• Provide support to Validation Management to complete validation activities and keep company in FDA compliance.

• Participate in audits and regulatory agency inspections as a representative of the Engineering Validation team.

• Demonstrate continuous improvement concerning increasing job knowledge and proficiency related to validation in the pharmaceutical industry, and technical understanding capability.

Knowledge, Skills & Abilities:

NOTE: The primary accountabilities and the knowledge, skills and abilities listed are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager.

• Bachelor's Degree in Science or Engineering (4 year) from regionally accredited university or Associate Arts Degree (2 year) and 3 plus years of relevant experience.

• 2 to 4 years of combined validation experience with equipment, utilities or facilities within a cGMP or FDA regulated environment preferred.

• GMP/cGMP change control process experience.

• Knowledge of industry regulated guidelines for the validation of cGMP facilities

• Relevant experience within the Pharmaceutical or Biotechnology industries

• Excellent verbal and written communication skills

• Microsoft Word, Power Point, Excel, Access, Minitab. Good communication and interpersonal skills. Organizational Skills.

• Specific expertise, skills and knowledge within quality assurance gained through education and experience.

• The ability to take strategic objectives and accept accountability to drive results through effective actions.

• The ability and willingness to change direction and focus to meet shifting organizational and business demands.

• The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.

• The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.

• The ability to manage a multitude of resources and to be accurate and current with data and information.

• Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (60%), walking, and hearing.

• Additional Requirements:

• Salary range: Based on experience

EEO Statement:

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.

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