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/contractorsReviews and approves complex design concepts and analysis of technologies that incorporate own area of expertise as well as multiple disciplines, as applicableReviews 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 trackingProvides leadership to assess and provide guidance and risk assessments regarding validation and compliance requirements in own area of expertiseAssist and guides the strategy and requirements of how validation is to be accomplishedApproves protocols and support documentationPrepares regulatory submissions and presents validation dossiers to regulatory authorities during routine internal and regulatory inspectionsSupports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelinesLeads projects with complex featuresOther responsibilities as needed

 

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 resultsAbility to influence outside of immediate scope of responsibilityDirect 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