Principal GxP Computerized Systems Engineer

Written By Dan Swanson
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TITLE: Principal GxP Computerized Systems Engineer

DEPARTMENT: Operations

REPORTS TO: Associate Director Professional Service Operations

CLASSIFICATION: Exempt (salary)

STATUS: Full Time 

LOCATION: Varies Between Remote and at a Client Site

cGMPnow 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 SUMMARY:   

The 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 & BENEFITS:

Salary Compensation Range: $200,000 - $300,000

This 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.

QUALIFICATIONS:

Must 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.  

 REQUIREMENTS:

  • Bachelor 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 required

  • 10+ years relevant GxP OT system deployment and CSV experience, preferably in the biotech / pharma industry

  • Direct experience with manufacturing automation and/or laboratory systems supporting GMP manufacturing  

  • Direct experience implementing GMP computerized systems under a GAMP/SDLC framework

  • Thorough understanding of GxP data governance and data integrity regulations and guidances 

  • Direct experience with developing GxP ITOT System Architecture, Automation & Controls Plan and Data Governance Plan for IT/OT systems

  • Experience in an cGMP FDA regulated industry 

  • Experience 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 plus

  • Experience 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 plus

  • Experience 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 plus 

  • Demonstrated commitment to staying current with GxP regulations, OT infrastructure innovations, and the application of AI/Machine Learning within regulated environments

ESSENTIAL FUNCTIONS and RESPONSIBILITIES: 

  • Lead, develop and revise OT System deployment and CSV project plans, work breakdown structures and schedules

  • Lead 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 CSV

  • Provide project management to integrators and/or other contractors/vendors to ensure project goals are met

  • Lead meetings with project stakeholders and contractors to ensure project objectives are being met with respect to scope, budget and schedule

  • Work 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 principles

  • Develop 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 technologies

  • Work with stakeholders to understand complex problems and focus on bringing issues to resolution, escalating as necessary to meet timelines

  • Ability to work in a highly regulated industry and follow corporate procedures for project execution, design documentation, change control management, and good documentation practices

SKILLS:

  • Strong candidate will possess the following key attributes:

    • Team player, hands-on attitude, willingness to be actively involved

    • Hard working, driven, results-oriented and focused on success

    • High ethical standards and integrity

    • Ability to perform work with little to no direction

  • Effective oral and written communication

  • Personal computer and keyboarding

  • Customer service including attentive and active listening with management, employees, vendors and customers  

  • Critical thinking and problem solving

  • Time management, organizational and planning processes

KNOWLEDGE:

  • Strong knowledge of FDA and cGMP regulations and documentation practices

  • Strong knowledge of 21 CFR Part 11 and Annex 11

  • Background 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 E2500

  • Ability to work both independently and cross-functionally with IT, QA, and Site organizations in a dynamic, ever-changing environment

  • Experience managing external vendors and subcontractors

  • Operating 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 programs

  • Google Suite proficient 

ABILITIES:

  • Manage multiple priorities and multi-task with frequent interruptions

  • Flexible in times of change and adapt to changing environments and priorities

  • Take initiative and plan ahead

  • Maintain a good attitude while working under pressure and defuse stressful situations

  • Work in a team environment and work effectively with other departments to accomplish goals

  • Work independently with little or no supervision  

  • Plan, conduct and attend meetings in person or via teleconference software

OTHER:

  • Willing to travel regionally up to 25% of the time

  • Willing to travel locally, within 60 miles of residence, for full time support at client site

  • Must have access to a stable home office internet connection with sufficient bandwidth to participate effectively in web-based meetings and teleconferences

  • All other duties as assigned 

PHYSICAL REQUIREMENTS:

The 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).

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by the employee(s) within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees in this position.  Job descriptions are not intended as and do not create employment contacts.  The organization maintains its status as an at-will employer.

Dan Swanson