Rocket Pharma is seeking a high energy, motivated candidate for Validation Engineer.
The successful candidate will join a well-funded (public, NASDAQ: RCKT) clinical-stage LVV and AAV gene therapy company (biologics) with a broad pipeline in multiple pediatric rare disease clinical indications in US & EU.
This technical position is a key role in manufacturing operations and quality. The ideal candidate will have relevant industry experience in pharma, biotechnology, cell, gene or regenerative medicine; or similar industry experience at a leading biotech organization.
As a Validation Engineer, you will be responsible for planning, developing, implementing and monitoring Rocket’s validation strategy. This role will ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products. The Validation Engineer will establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for later analysis. They will coordinate with other personnel or departments who will be affected by validation testing. Validation responsibilities include feedback on equipment budgeting, purchasing, monitoring and testing. The successful candidate will have appropriate experience with industry standards and regulatory guidelines and is expected to oversee the work of validation technicians/contractors. The Validation Engineer will compose reports and make adjustments to equipment or processes that require improvement.
The ideal candidate will also have a strong passion and curiosity for science and gene therapy with the desire to bring needed cures from bench to bedside. Demonstrated genuine interest and curiosity in research and process development highly valued.
- Develop, execute, and drive to approval/closure all manufacturing validation protocols;
- Assist Manufacturing in deviation investigations and implementing CAPAs;
- Collaborate with Manufacturing, Supply Chain, CMC, Facilities, QC, and QA teams as “customers” during investigation process;
- Assist Manufacturing with technical transfer from external parties, or with the implementation of cGMP facility and equipment continuous improvements;
- Help maintain cGMP manufacturing process database; perform basic and complex data analysis; interpret and draw conclusion from scientific and process data sets as it relates to validation requirements;
- Assist Manufacturing with the establishment of validation cGMP systems and documents;
- Develop validation master plans, process flow diagrams, test cases, or standard operating procedures;
- Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production;
- Assist in training equipment operators or other staff on validation protocols and standard operating procedures;
- Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies;
- Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols;
- May represent Manufacturing as Validation Subject Matter Expert (SME) during internal audits and regulatory inspections;
- Build relationships within the company and with external parties, such as suppliers or vendors;
- Assist Manufacturing Management to identify and determine best vendors and suppliers;
- Assist Manufacturing with internal safety and quality inspections and audits;
Education/Experience and Skills Requirements:
- Previous work experience in Pharma/biologics Manufacturing and Validation for 4+ years (position level dependent upon candidate experience);
- Bachelor’s degree in electrical or mechanical engineering, biotechnology, computer science or related field
- Direct experience investigating cGMP manufacturing deviations and non-conformances using industry accepted Root Cause Analysis tools
- Demonstrated ability to collect, organize, analyze, interpret and draw conclusions from manufacturing process data;
- Must have experience with GMP/regulated manufacturing environments and materials;
- Experience establishing cGMP systems and documents;
- Working knowledge of cGMP facility and utility validation and environmental monitoring programs and principles;
- Working knowledge of cGMP equipment validation, operation and maintenance;
- Direct experience with quality documentation and Quality Management Systems;
- Demonstrated ability to work under minimal supervision and drive tasks to completion under aggressive timelines;
- Sense of ownership and pride in your performance and its impact on company’s success;
- Critical thinker and problem-solving skills;
- Team player;
- Demonstrated ability to manage multiple tasks and prioritize work;
- Great interpersonal and communication skills;
Location: Cranbury, NJ
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
About Rocket Pharma
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs. www.rocketpharma.com.
Search Firm Representatives Please Read Carefully
Rocket Pharma is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Rocket Pharma via-email, the Internet or directly to hiring managers at Rocket Pharma in any form without a valid written search agreement in place for that position will be deemed the sole property of Rocket Pharma, and no fee will be paid in the event the candidate is hired by Rocket Pharma as a result of the referral or through other means.
*Please note, only qualified applicants that meet the requirements for the position will be contacted. This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
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