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Vigene Biosciences Manager, Engineering & Validation in Rockville, Maryland

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.

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