Careers | Vigene Biosciences

Careers

Careers at Vigene

Headquartered in Rockville, Maryland, Vigene Biosciences is a rapidly growing company that strives to be a leading manufacturer of viral vectors. We are proud to support researchers at any stage of development: from basic research, to animal studies, to clinical trials and commercialization. Our diverse customer base includes scientists all across the world from academia, government organizations, research institutes, biotechnology companies, and pharmaceutical companies.

We are passionate about our mission to help support scientists advance their biomedical research and ultimately to make gene therapy affordable and available to those in need. As we continue to grow, we are always looking for talented people to join our team who share our passion. We value our employees as important contributors to our mission, so we provide opportunities for career growth and encourage employees to develop new skills so they can grow with our company.

Equal Opportunity Employer

Vigene Biosciences is an EEO/AA employer. Vigene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law. If you need reasonable accommodation for any part of the employment process, please contact us by email at jobs@vigenebio.com and let us know your request and contact information. Please note that only inquiries concerning a request for reasonable accommodation will be acknowledged from this email address. Requests for accommodation will be considered on a case by case basis.

Benefits

  • Healthcare benefits (Medical and Dental/Vision Insurance)
  • 100% Company Paid Life Insurance
  • 100% Company Paid Accident Insurance
  • Short and Long Term Disability Insurance
  • Paid Vacation, Floating Holidays and Sick Leave
  • 401(k) Plan with Safe Harbor Match
  • Employee Assistance Program
  • Dependent Care and Commuter/Transit FSA
  • Adoption Assistance
  • Education Assistance
  • Competitive Salary and Performance Bonus
  • Career development opportunities
  • Work-Life Balance
  • Fun, collaborative environment

Manager, Engineering & Validation

Job Title
Manager, Engineering & Validation
Location
Rockville,  MD 20850
Other Location
Description

Department: Facilities

Reports to: Director, Facilities & Central Services 

Location: Rockville, MD

Company Overview

Vigene Biosciences, Inc. is an award winning CDMO that provides viral vector-based gene delivery services and products for research and clinical applications. We are proud to support scientists at any stage of research: from basic research, to animal studies, to clinical trials and commercialization. Our diverse customer base includes thousands of scientists all across the world from academia, government organizations, research institutes, biotechnology companies, and pharmaceutical companies.

Job Summary:

This position supports site projects and ongoing validation. Primarily responsible for the design, authorship, and execution of commissioning, qualification and/or validation studies for any or more of the following major disciplines: 

  • Facilities, Utilities, and Equipment (FUE) qualification 
  • Units operations automation qualification  
  • Computerized systems validation 
  • Cleaning validation 
  • Sterilization validation 
  • Materials validation 
  • Process validation 

Manages successful completion of projects within boundaries of quality, time, and budget. Based on significant technical expertise, reviews and approves complex design concepts. Provides technical direction to staff. Recognized as expert by peers and other personnel within the business. Displays general understanding of theories/practices of a variety of validation disciplines. 

Essential Duties & Responsibilities: 

  • Manages a variety of complex issues in associated projects, plans and schedules project implementation. Responsible for defining scope of work for functional team/contractors
  • Reviews and approves complex design concepts and analysis of technologies that incorporate own area of expertise as well as multiple disciplines, as applicable
  • Reviews and analyzes proposals to determine if benefits derived and possible applications justify expenditures. Responsible for preparation of project cost estimates. Monitors all project expenditures and cost tracking
  • Provides leadership to assess and provide guidance and risk assessments regarding validation and compliance requirements in own area of expertise
  • Assist and guides the strategy and requirements of how validation is to be accomplished
  • Approves protocols and support documentation
  • Prepares regulatory submissions and presents validation dossiers to regulatory authorities during routine internal and regulatory inspections
  • Supports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines
  • Leads projects with complex features
  • Other responsibilities as needed

Non-Essential Duties & Responsibilities: 

  • n/a 

Supervisory Responsibilities: 

  • n/a 

Knowledge & Other Qualifications: 

  • Bachelor's degree in science, engineering or other related technical field 
  • A minimum of 3 years of relevant experience in a GMP regulated environment 
  • At least 3 years of commissioning, qualification, and validation (CQV) required 
  • At least 2 years of salaried professional supervision experience required 
  • At least 2 years of project management experience highly desired 
  • Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments 
  • Validation and/or system experience in the following applicable areas: 
    • Sterilization and aseptic filling validation 
    • Cleaning validation of manufacturing equipment 
    • Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification 
    • Technical understanding and experience of automation platforms, such as OSI PI data historian, Honeywell, Rockwell, Siemens 
  • Ability to effectively lead projects, coordinate contractors, mentor team of technical validation engineers and scientists, and drive results
  • Ability to influence outside of immediate scope of responsibility
  • Direct experience with manufacturing operations and biotechnology processes required

Other Characteristics: 

  • Excellent communication and attention to detail 
  • Strong organizational skills, excellent writing and communication skills 
  • Proficiency with Microsoft Office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus 
  • Must be well versed in validation disciplines. Must possess knowledge of related disciplines 
  • Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience 
  • Has demonstrated effective leadership and supervisory skills 
  • Authorized to legally work in the United States without visa sponsorship 

Physical Requirements/Work Environment/Travel Requirements: 

  • Reliable mode of transportation to travel between sites in the Rockville area 
  • Able to work standing, sitting, twisting, stooping, walking, bending, and reaching overhead for long periods of time 
  • Able to work around various cleaning chemicals that produce non-hazardous odors like bleach and vinegar 
  • Able to wear appropriate gowning covering most parts of the body and face 
  • Able to lift, push, and pull 50 lbs. 

Vigene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

Job Type: Full-time

COVID-19 considerations:
We have established multiple policies to protect our employees' health & safety while allowing essential operations to continue following social-distancing & PPE guidelines. Non-essential departments are working remotely and/or working alternative hours.

Required Skills

GMP
Facilities
Engineering
Openings
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