Agile PLM Engineer
Fully remote
6 month contract to hire
This individual will provide CSV/Assurance support for computerized systems, networks and software that have been newly
installed, upgraded and/or modified to support cGMP functions in Manufacturing, Supply Chain, and Quality. As part of IT Quality
and Compliance organizations. Work closely with Change Owners to generate and support validation/assurance testing (IQ, OQ, IOQ,
PQ etc.) that are compliant with Plant and Corporate policies and procedures.
Responsible for reviewing, executing, documenting and approving assurance testing/validation deliverables, and if necessary
manage contract resources to generate and or execute validation documents and activities.
Job Responsibilities:
 Ensure validation packages contain all relevant information, rationales, references, and data to support the change and that
all reports and protocols are reviewed and approved as appropriate
 Initiates, leads and authors cGMP risk assessment, gap analysis, and deviation management associated with validation
programs with precise document writing following Good Documentation Practices (GDocP) with clarity to meet the set
forth expectations
 Ensure Validation Plans and strategies are in alignment with validation policies, procedures and guidelines and external
regulatory requirements, and European and International standards
 Interact with QA, IT, Engineering and business area users to understand functionality and use of automated control systems
 Review and provide feedback to plant and corporate policy writers on CSV guidelines, specifications and policies
 Coordinate tasks with validation technician(s) and validation consultants to provide project and technical direction, as
needed
 Must be able to manage complex projects, set/achieve timelines, direct/redirect resources and manage assigned funding
 Plan and lead revalidation of computer systems
 Own tasks related to periodic reviews, and remediation activities on validated systems. Plans and/or executes these
validation protocols
 Participate on investigation teams in the event of adverse validation trends/failures to identify root cause and
corrective/preventative actions. Expected to bring validation expertise and strong analytical and systematic problem solving
skills
 Write or assist with the writing of Standard Operating Procedures, Business/Software Requirements and Validation Master
Plans
 Must maintain a thorough working knowledge of the ICU Medical Systems and Validation requirements
 Must be able to work extended schedules as required to meet deadlines
 Perform other related duties as assigned or required
Knowledge, Skills & Qualifications:
 Must have experience and functional knowledge of Good Automated Manufacturing Practice (GAMP), cGMP, SDLC, Risk
Assessment, EU Annex 11 and 21 CFR Part 11 Electronic Records and Electronic Signatures
 Working knowledge of Oracle Agile PLM, Oracle EBS is required
 Working knowledge of data migration, sampling methods
 Experience in one of the following disciplines is required: Manufacturing, Facilities/utilities, Pharma/Solution processes,
Sterilization, IT Applications and/or Controls systems/software
 Must have good organizational, presentation, meeting facilitation and technical writing skills
 Requires a high level of resourcefulness, an ability to get things done by removing obstacles, perceiving and resolving
problems, make recommendations when less than complete information is provided, and finding ways to accomplish goals
through innovative planning
 A high level of attention to details and the ability to proofread and audit validation documents is required
Education and Experience
 Requires a BA/BS in a Computer Science, Information Systems, or other related field in sciences. Masters’ degree is
preferred.
 8+ years' experience in IT analysis, design and implementation including 2+ yrs with Oracle Agile PLM or similar QMS system
 Min 3 years direct experience of computer systems validation/assurance
 Masters’ degree is acceptable in lieu of 2 years of experience
 Requires strong, demonstrable knowledge of :
 Multiple SDLC development process (Scrum, XP, Kanban, etc.)

Experience with 3rd party vendor integrations
Travel Requirements
 Typically requires travel less than 5% of the time
 Physical Requirements and Work Environment
 This is largely a sedentary role.
 This job operates in a professional office environment and routinely uses standard office equipment.