Cambrex Corporation Hiring for CSV Specialist job in East Rutherford Full Time

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

engage in work that matters to our customers and the patients they serve
learn new skills and enjoy new experiences in an engaging and safe environment
strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

Job Overview

Cambrex (www.Cambrex.com) is seeking a highly motivated, energetic, results-oriented individual to join our team of dedicated professionals focused on customer service and quality. This role will be responsible for managing and executing GxP CSV projects from project kickoff through system go-live. Project will range in size from simple off the shelf systems to large enterprise systems. This is primarily a remote position that will require periodic onsite visits to support projects activities. Onsite support is estimated to be once a month but will be dependent on project requirements and schedule.

Responsibilities

– Works closely with project stakeholders (IT, System Owner, QA) to effectively and efficiently implement new systems, system upgrades, or system modifications – Develops and manages project schedules to drive efficient projects executions – Manages consultants to ensure that project timeline, budget, and quality are maintained – Manages CSV projects under a GAMP lifecycle framework – Writes, reviews, approves and executes all system lifecycle documents (URS, Validation Plan, Specifications, Risk Assessment, Qualifications IQ/OQ/PQ, Data Integrity Evaluations, Trace Matrix, SOP’s, Validation Summary Report) – Conducts data integrity evaluations and enforces the required data integrity controls – Supports client and regulatory audit activities – Assist in development, implementation, and enforcement of computer system validation and data integrity policies and practices

Qualifications/Skills

– Strong understanding of 21CFR Part 11 and Data Governance/Data Integrity requirements – Strong experience with technical writing, risk assessment, gap analysis, change control and deviation management

Education, Experience & Licensing Requirements

BS/BA – At least 5 years of experience managing and executing Computer System Validation projects in a GAMP framework – At least 3 years of project management experience

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.