- Facilities, Utilities, and Equipment (FUE) qualification
- Units operations automation qualification
- Computerized systems validation
- Cleaning validation
- Sterilization validation
- Materials validation
- Process validation
- 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
- 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
- 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
-
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Manager, Engineering - Rockville, United States - latitude
Description
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:
Essential Duties & Responsibilities:
