Manager, Engineering

3 weeks ago

Rockville, United States CareerBuilder Full time

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
Computerized systems validation
Process validation
Managessuccessful 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.
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
Knowledge & Other Qualifications:
Bachelor's degree in science, engineering orotherrelated 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, excellentwritingand communication skills
Proficiency with MicrosoftOffice 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

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