Sr Engineering Documentation Specialist

Lantheus Medical Imaging

Documentation

October 21, 2014

Purpose / Summary
  • Provide managerial leadership to ensure the safe, compliant and cost effective management and administration of engineering department documentation in support of LMI facility, process, and manufacturing operations.  Is Accountable to independently plan, organize, lead and control all aspects of ownership of LMI’s engineering documentation.  This role exhibits the competent leadership to orchestrate all aspects of GFE engineering document administration as it relates to the document lifecycle (author, approve, publish, revise, retire, archive) for engineering /construction documents and other related business policies, procedures, and technical documentation.
  High-Level Accountabilities                                                                           
  • Manage engineering / technical project and record documentation
  • Develop, implement, manage, and distribute engineering change management process
  • Coordinate, prepare, receive, review, and implement engineering design and documentation changes
  • Create and check documentation in support of engineering projects ensuring that engineering standards and procedures are met
  • Provide technical assistance to internal & external design engineering professionals to ensure accurate design and as-built documentation
  • Ensure alignment with Quality change management process and continuously improve compliance
  • Demonstrate LMI values
  • Model work ethics & expectations
  • Ensure LMI safety
  • Ensure regulatory compliance
  • Provide leadership in Operations Excellence
  • Establish & Monitor related metrics with emphasis on improved performance
  • Ensure that documentation standards and procedures keep pace with current industry practices and business requirements
  • Communicate proactively across LMI
  • Represent GFE and LMI, as appropriate
  • Demonstrate confidence to GFE staff
  • Be an competent Leader in LMI
  • Handle conflict appropriately
  • Be an Advocate of the Business
  • Be a Good steward of company funds
Essential Functions
  • Safety Leadership
    •  Is responsible for modeling, monitoring, driving and ensuring safe work practices are employed by all GFE resources and contractors.  Must have the leadership skills to establish zero tolerance for unsafe work practices.  Must have the skills to recognize unsafe conditions or behaviors and exhibit the senior leadership wherewithal to challenge any level of personnel to be in compliance.  Must exhibit good judgment and tact in driving safe practices and behaviors.
  • Radiological Safety leadership
    • Is responsible for modeling, monitoring, driving and ensuring safe radiological work practices are employed by all GFE resources and contractors.  Must have the leadership skills to establish zero tolerance a lack of discipline to radiological work practices.  Must have the skills to recognize unsafe radiation safety conditions or behaviors and exhibit the senior leadership wherewithal to challenge any level of personnel to be in compliance.  Must exhibit good judgment and tact in driving safe practices and behaviors.
    • Must ensure a behavior of discipline to radiological safety practices
  • GMP Compliance Ownership/leadership
    • When requested, acts as the primary GFE SME with regulatory agencies (e.g., FDA, NRA, EPA, OSHA) and, for validation and commissioning of operations.
    • Must ensure a behavior of discipline to compliance requirements and a discipline to adherence to SOPs.
    • Owns ensuring all compliance documentation and quality requirements are adhered to.
  • Engineering Documentation Management Ownership/Leadership
    • Owns ensuring all engineering documentation is continuously available to support manufacturing operations.
    • Strong proactive research, anticipation and prediction of problems that could affect engineering documentation.  Must model behavior of preparing and providing layers of protection from potential impacts.  Must be aggressive in soliciting forward looking planning to be prepared well in advance of upcoming activities or events.
    • Be a LMI subject matter expert (SME) on engineering documentation and CADD
    • Support capital or expense  budgeting through proactive long-range identification of funding needs to support engineering documentation management
    • Provides leadership and support activities associated with capital projects to ensure documentation provided by external parties complies with LMI CADD or documentation standards and are provided in the appropriate format.
    • Owns creation and maintenance of engineering documentation standards.
    • Establish and ensure compliance with lifecycle management of all engineering documentation.
  • People Leadership
    • Creates a positive organizational culture of camaraderie and engagement.
  • Values & Integrity leadership
    • Promotes and demonstrates the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.
    • Must model integrity and set the standard for subordinates to emulate
  • Metrics/Operational Excellence Leadership
    • Must utilize operational metrics to achieve operational excellence
  • Communications leadership
    • Appropriately communicates strategic and technical information that may affect business and/or functional activities.
    • Must be capable of creating profession and succinct presentations and be capable of articulately presenting the same.
  • Leadership
    • Exhibit strong leadership to recognize, own and resolve LMI engineering documentation problems, issues, barriers, or obstacles.  Must be aggressive in demonstrating proactive leadership to the organization.
    • Innovate competent and world-class strategies to deliver and advance all aspects of engineering documentation proactively.
    • Ability to recognize organizational obstacles, barriers, limitations and problems then develop and implement strategies to resolve those, as well as to develop the organization.
    • Demonstrates ownership and support for all LMI senior management decisions.
    • Exhibits good managerial judgment
  • Development
    • Is responsible to pursue continuing education in pharmaceutical manufacturing technologies, FDA compliance requirements, radiological compliance requirements, asset care and any applicable manufacturing technologies that could offer a competitive advantage to LMI’s manufacturing business.   Also responsible to pursue continuing education in six sigma and Operations Excellence.
  Engineering Documentation Manager Typical Minimum Skills and Experience and Education
  • 5+ years of experience with engineering documentation management within the pharmaceutical, biotech or a comparable highly regulated environment.
  • Advanced knowledge of CADD applications
  • Knowledge of Documentation Management software applications
  • Demonstrated leadership capabilities
  Other Requirements
  • Roles requires normal eyesight, normal balance, normal mobility, ability to lift a minimum of 20 lbs, ability to climb a 20 foot vertical ladder, ability to sit or stand for prolonged periods.
  • Ability to travel 5%.
  • Advanced computer skills, including Microsoft Office Suite, advanced knowledge of Excel
  • Hands on expert knowledge of CADD applications
  • Hands on knowledge of engineering documentation management
  • Must have strong, competent and articulate written, oral and presentation communication skills and be able to interact effectively with senior management.
  • Must have strong interpersonal, behavioral and EQ skills.
  • Willingness to respond timely, at any time, 24x7, and in any weather conditions to address important issues or situations that could affect LMI manufacturing delivery or the LMI business.
  • Must have strong teaming skills.
Lantheus Medical Imaging is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, veteran status, disability or any other legally protected status.

Apply Now

  • Company Lantheus Medical Imaging
  • Contact Name Rick Tetreault
  • Position Location North Billerica, MA
  • Job Reference Code LMI 1403
  • Minimum Preferred Education Bachelor's Degree
  • Minimum Years Experience 5
  • Career Level Experienced Non-manager
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