Principal GxP Computerized Systems Engineer

TITLE: Principal GxP Computerized Systems EngineerDEPARTMENT: OperationsREPORTS TO: Associate Director Professional Service OperationsSTATUS: Full TimeLOCATION: Varies Between Remote and at a Client SitecGMPnow accelerates Next Generation Therapies to patients by providing GxP Manufacturing & QC Laboratory Equipment, GxP Computerized Systems, Commissioning & Qualification, and Procurement services using project-dedicated expert resources.With our unique project delivery methodology and owner-focused involvement, we bring new products to the market faster by providing cGMP systems faster.Position SummaryThe Principal GxP Computerized Systems Engineer is responsible for the implementation of GMP computerized systems in FDA & EU regulated Advanced Therapeutic Medicinal Product (ATMP) industries. The successful candidate will have experience managing and executing the implementation of GMP manufacturing and/or laboratory computerized systems under a GAMP/SDLC framework. Projects will range in size from simple off the shelf systems to large enterprise systems.Compensation & BenefitsSalary Compensation Range: $200,000 - $300,000This position is eligible for healthcare benefits with the employee premiums 100% paid for by the company, enrollment in a retirement savings plan with company contributions, company matching of charitable contributions, profit sharing and is eligible for paid time off. Training, conferences and professional registration dues are eligible for reimbursement.Please note that the salary information is a general guideline only. Other factors such as (but not limited to) scope and responsibilities of the position, candidate's work experience, education/ training, key skills as well as market and business considerations when extending an offer.QualificationsMust have excellent planning skills, be highly organized and detail oriented, able to manage multiple projects simultaneously and be able to adapt to changing environments and priorities. Must be a self-starter with the ability to work productively in a predominantly remote environment and meet benchmarks and goals in a timely fashion. Strong interpersonal communication and organizational skills are required. Experience in consulting firms preferred.RequirementsBachelor of Science Degree in Computer Science, Information Technology/Automation, Life Science, Engineering or related discipline, along with a minimum six years (Engineer IV)/eight years (Engineer V)/ten years (Sr Engineer) of progressive work experience required10+ years relevant GxP OT system deployment and CSV experience, preferably in the biotech / pharma industryDirect experience with manufacturing automation and/or laboratory systems supporting GMP manufacturingDirect experience implementing GMP computerized systems under a GAMP/SDLC frameworkThorough understanding of GxP data governance and data integrity regulations and guidancesDirect experience with developing GxP ITOT System Architecture, Automation & Controls Plan and Data Governance Plan for IT/OT systemsExperience in an cGMP FDA regulated industryExperience with process control systems including DeltaV and PLCs (such as Allen-Bradley ControlLogix), programming in ladder logic and instructional texts, and HMI screen development and management would be a plusExperience with implementing and maintaining Windows-based Operations Technology control systems and related components including Active Directory, User Administration, Network Communication, and backup systems would be a plusExperience with implementing ERP, VMS, QMS, CMMS, EMS, MES, IFN, PI Data Historian, QC lab systems (Empower, Softmax Pro, LabX) and associated LIMS that support advanced therapeutics would be a plusDemonstrated commitment to staying current with GxP regulations, OT infrastructure innovations, and the application of AI/Machine Learning within regulated environmentsEssential Functions and ResponsibilitiesLead, develop and revise OT System deployment and CSV project plans, work breakdown structures and schedulesLead efforts to solicit GxP OT System User Requirements and develop a high-level ITOT System Architecture Diagram and develop cost/schedule estimates for design, hardware, configurations, startup, and CSVProvide project management to integrators and/or other contractors/vendors to ensure project goals are metLead meetings with project stakeholders and contractors to ensure project objectives are being met with respect to scope, budget and scheduleWork closely with client project stakeholders (IT, System Owner, Automation, Engineering, QA) to effectively and efficiently implement new systems, system upgrades, or system modifications.Work closely with vendors and general contractors for facility design management support, design review and RFP process for facility and equipment automation and controls.Define requirements to procure and implement GMP computerized systems that are compliant with applicable GMP/Data Integrity/Data Security regulations and industry standards.Lead, develop, review and execute all computerized system core validation deliverables and life cycle documents (User Requirement Specifications, Functional Specifications, System Architecture Drawings, Configuration Specifications, Validation Plan, Specifications, Risk Assessment, Qualifications IQ/OQ/PQ, Data Integrity Evaluations, Trace Matrix, SOP's, Validation Summary Report)Support data integrity implementation and remediation for GMP computerized systems. Ensure compliance with 21 CFR Part 11, GAMP 5, Annex 11, and ALCOA+ data integrity principlesDevelop and maintain a controls implementation/data integrity strategy that integrates process knowledge, equipment design, and quality standards with information technology to reduce downtime, elevate the level of regulatory compliance, and introduce efficiency gains through effective use of available technologiesWork with stakeholders to understand complex problems and focus on bringing issues to resolution, escalating as necessary to meet timelinesAbility to work in a highly regulated industry and follow corporate procedures for project execution, design documentation, change control management, and good documentation practicesSkillsStrong candidate will possess the following key attributes:Team player, hands-on attitude, willingness to be actively involvedHard working, driven, results-oriented and focused on successHigh ethical standards and integrityAbility to perform work with little to no directionEffective oral and written communicationPersonal computer and keyboardingCustomer service including attentive and active listening with management, employees, vendors and customersCritical thinking and problem solvingTime management, organizational and planning processesKnowledgeStrong knowledge of FDA and cGMP regulations and documentation practicesStrong knowledge of 21 CFR Part 11 and Annex 11Background in Lifesciences and/or Pharma/Biotech industries (or understanding of bioprocessing and support processes)Knowledge of current industry standards such as GAMP 5 and ASTM E2500Ability to work both independently and cross-functionally with IT, QA, and Site organizations in a dynamic, ever-changing environmentExperience managing external vendors and subcontractorsOperating standard office equipment including; personal computers, peripherals, and typical office equipment (telephone, copier, printers, scanners, etc.)Microsoft Office Suite (Word, Outlook, PowerPoint, Excel) and other related software programsAbilitiesManage multiple priorities and multi-task with frequent interruptionsFlexible in times of change and adapt to changing environments and prioritiesTake initiative and plan aheadMaintain a good attitude while working under pressure and defuse stressful situationsWork in a team environment and work effectively with other departments to accomplish goalsWork independently with little or no supervisionPlan, conduct and attend meetings in person or via teleconference softwareOtherWilling to travel regionally up to 25% of the timeWilling to travel locally, within 60 miles of residence, for full time support at client siteMust have access to a stable home office internet connection with sufficient bandwidth to participate effectively in web-based meetings and teleconferencesAll other duties as assignedPhysical RequirementsThe position requires intermittent physical activity of sitting, standing, walking, bending, stooping, crouching and lifting up to 25 pounds on occasion. If you cannot do one of these physical requirements cGMPnow will make reasonable accommodations. Must be able to talk, write and understand the English language. Able to type/keyboard or enter data using a computer up to 8 hours per day. Must possess normal manual dexterity and eye-hand coordination.cGMPnow is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: cGMPnow is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, family or parental status, or any other status of a protected class by the laws or regulations in the locations where we operate. cGMPnow will not tolerate discrimination or harassment based on any of these characteristics.The term "protected class" refers to groups of people who are legally protected from being harmed or harassed by laws, practices, and policies that discriminate against them due to a shared characteristic (e.g. race, gender, age, disability, or sexual orientation).#J-18808-Ljbffr