Job Description

Validation Engineer / Validation Manager

At Genetic Design and Magic Corporation (GDMC), our mission is to exponentially increase the availability of genetic medicines and change millions of patients’ lives. We achieve this by partnering and supporting early-stage companies and investigators with innovative therapeutic modalities such as gene therapies or nucleic acids. Leveraging our expertise in process development and manufacturing, we accelerate our partners ability to bring their ideas through clinical trials and into market. We are growing quickly and looking for talented individuals eager to build something new, challenging and impact lives with transformative medicines. GDMC is expanding our Manufacturing team and is seeking exceptional Validation Managers. As a Validation Manager in Manufacturing, you will be validating the processes and equipment need by our partners for their manufacturing campaigns. You will work closely with the rest of the Manufacturing team as well as Quality team to ensure high standards of quality in our facility. You will also be exposed to best in class manufacturing cGMP suites and learn the latest technologies for manufacturing genetic medicine. If you’d like to play a part in bringing the next life-saving innovations to market, we want you! GDMC is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to achieving a diverse workforce through application of equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, terminations, salary administration, benefits

Responsibilities

• Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.

• Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.

• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.

• Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.

• Identifies root causes of production problems.

• Identifies nonconformities of product or process standard and offers recommendations for resolving deviations.

• Develops and maintains databases for tracking test results, validation activities, or validated systems.

• Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices.

• Modifies testing methods or revisits test objectives and standards to resolve testing problems.

• Calibrates equipment to ensure accurate measurements.

• Performs other related duties as assigned.
  

Job Requirements

• Bachelor’s degree in mechanical or Electrical Engineering preferred. Life sciences or related fields are also welcomed to apply.

• 2 – 5 years’ experience as validation engineer or similar role, preferably in biopharmaceutical industry

• Thorough understanding of industry standards in biopharma / biomanufacturing and regulatory guidelines

• Attention to details

• Excellent mathematical skills and analytical skills

• Excellent organizational and interpersonal skills

• Highly motivated, passion for science, committed to laboratory work and able to work flexible hours

• Ability to multitask, work independently and also as part of a team. Excellent communication (verbal and written) and presentation skills