Engineering Project Manager at Nephron Pharmaceuticals in West Columbia, South Carolina

Job Description:

Nephron Pharmaceuticals


Description:

Corporate Statement:

Nephron Pharmaceuticals 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, ophthalmic, 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. 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 some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust.

Job Purpose:

The Pharmaceutical Manufacturing Engineering Project Manager is responsible for overseeing and managing engineering projects within pharmaceutical manufacturing facilities. This role ensures that projects are completed on time, within budget, and in compliance with regulatory standards. The Project Manager will work closely with cross-functional teams, including engineering, quality assurance, production, and regulatory affairs, to deliver successful project outcomes.

Essential Duties and Responsibilities:

· Plan, execute, and monitor pharmaceutical manufacturing engineering projects from initiation to completion.

• Develop detailed project plans, including scope, timelines, resource allocation, and budgets.
• Ensure projects meet quality, safety, and regulatory standards in accordance with FDA, GMP, and other applicable guidelines.
• Collaborate with engineering teams to design a implement equipment, systems, and processes for pharmaceutical production.
• Manage stakeholder communication, including providing regular progress reports and facilitating meetings.
• Identify and mitigate project risks and resolve any issues that arise during project execution.
• Conduct post-project evaluations and implement lessons learned for continuous improvement.
• Ensure proper documentation and validation of manufacturing systems and processes.

Supplemental Functions:

• Performs other similar duties as required.

Job Specifications and Qualifications:

Knowledge & Skills:

• Minimum of 5 years of experience in pharmaceutical manufacturing, engineering, or project management.
• Technical background preferred, with strong knowledge of cGMP, and FDA regulations.
• Proven ability to manage multiple projects and prioritize tasks effectively.
• Excellent leadership, communication, critical thinking, analytical and problem-solving skills.
• 1–3 years of experience with Project Management Software, Microsoft Office Suite to include Word, Excel, and PowerPoint preferred.
• Knowledgeable in Adobe Acrobat (PDF) advanced features and workflows
• Discretion in handling sensitive and confidential information.
• Strong organizational skills with the ability to manage multiple projects or assignments simultaneously.

Education/Experience:

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, or related field); Master's degree preferred.
• Project Management Professional (PMP) certification is a plus.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.

The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description.

Nephron Pharmaceuticals 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, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.

Requirements:

Equal employment opportunity, including veterans and individuals with disabilities.

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