Technical Production Specialist/Sr Technical Production Specialist

Grifols Inc. Clayton , NC 27527

Posted 5 months ago

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Packaging

Hiring Manager: David Strickland

Level: M6/M8

Summary:

The Senior Technical Production Specialist assesses the department technical training needs, sources and/or develops the training curriculum, facilitates training, and manages the tracking of employee training. In addition, this person performs tasks in scheduling, environmental monitoring, support projects, document generation and authoring, and serve as a point of contact to troubleshoot after hours call support relating to process, equipment documentation and facility issues.

This role may also entail the investigation of process discrepancies.

Primary responsibilities for role:

  • Must be able to perform all responsibilities described in the Technical Production Specialist job description.

  • May supervise a small group of employees.

  • Lead teams on projects, documentation, training, safety, etc. which may involve employees in other BU

  • Responsible for allocation of resources at division/department level for projects and incident resolution.

  • Provide input for budget forecasting for production scheduling and operations.

  • Advances technical project proposals to Senior Management, following through to successful completion.

  • Independently lead type (1) incident investigations .

  • Serve as an SME for manufacturing process, equipment, workflow, documents, projects and training.

Requirements:

  • BS/BA degree in a relevant field and 6 years of related experience. An equivalent combination of education and experience may be considered.

In addition must be a SME in 5+ Unit Operations and 2 functions or 2 departments.

Unit Operations are defined as: Aseptic Processing, Filtration, Chromatography, Centrifugation, Lyophilization, Packaging/Labeling, Cleaning, Sterilization, Mixing, Laboratory Technique, Plant Utilities, GMP Utilities, Formulation, and Viral Inactivation. Functions are defined as: Investigations, Documentation, Projects, Technical Support, SAP/Bioman, CIP, Compliance, and Scheduling. Departments are defined as: Clarification, Fractionation, IGIV, Purification, Filling/Packaging, Site Engineering, Technology, and Quality Operations

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton

Learn more about Grifols


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Validation Area Specialist Aseptic Production

Novo Nordisk

Posted 4 days ago

VIEW JOBS 10/20/2019 12:00:00 AM 2020-01-18T00:00 At Novo Nordisk, we want to make a difference. For more than 95 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Help us bring quality to life. We are currently seeking top talent for our two pharmaceutical manufacturing facilities in Clayton, NC. Working at our fill/finish facility (DFP) Make What Matters Our 457,000 square foot aseptic "fill and finish" manufacturing facility in Clayton, NC, currently employs more than 850 people. The facility is part of a global network of manufacturing sites responsible for several key steps in the diabetes treatment manufacturing process, including sterile formulation, filling, inspection, device assembly and packaging. Producing medicines is a special responsibility. Our employees are passionate about what they do, knowing that their work makes a difference to millions of people who rely on our products every day. Join us and help make what matters. Position Purpose: Perform Revalidation & Periodic System Evaluations (PSE) on equipment/processes per approved timelines. Support validation activities associated with changes to existing & new systems. Processes include formulation, sterilization, cleaning, filling & inspection. Accountabilities: * Perform, review & approve revalidation & PSE activities. Must be able to work & communicate effectively across multiple departments to schedule & perform revalidation & PSE assignments. * Review & approve documents in accordance with local, corporate & regulatory regulations. * Collaborate, review & approve IQ, OQ & PQ protocols for systems/processes per approved timeframes. * Support and/or lead the closure of investigations per approved timeframes using root cause analysis techniques. Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures. * Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria. * Responsible for Change Requests (CR's) related to revalidation & other validation activities for AP. * Review & approve validation procedures, specifications & quality documents for accuracy & compliance. * Presentation & support for validation concepts & approaches with audits & inspections. * Follow all safety & environmental requirements in the performance of duties. * Operate in alignment with NNWay, demonstrating a Quality & cLEAN® Mindset. * Other accountabilities, as assigned. Required Education: BS in Engineering, Computer Science, or applicable scientific or technical degree. Required Experience: 2+ years validation related discipline experience in pharmaceutical or medical device industry. Technical/Process/Functional Knowledge: * Experience in quality concepts including technical & compliance review of validation & quality documents. * Experience in one or more core validation areas (sterilization, cleaning, process or computer validation). * Experience in cGMP documentation practices & regulations. * Basic computer skills including experience in the use of Microsoft word, Excel, etc. * Knowledge of statistical methods. * Strong oral & written communication skills. * Experience with validation test equipment including temperature mapping equipment (for example: Kaye Validator), desired. * Experience in project team collaboration & support. * At least 1 year of demonstrated experience using root-cause analysis techniques to solve problems. Organization/Planning: Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams. Physical Requirements: * Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions. * Constantly operates a computer & other office equipment using hands. * Able to work in an open office environment with the possibility of frequent distraction. * Able to work the hours necessary to support a 24/7 continuous manufacturing operation. * Able to adjust schedule to work with colleagues in other international time zones. Life-Changing Careers with Novo Nordisk With a local presence for more than 25 years, Novo Nordisk is one of the largest employers in Johnston County, with over 1,200 highly-skilled and dedicated employees working in Clayton and a diverse, global workforce of more than 40,000. We aspire to operate in a socially responsible way, and we are committed to offering a healthy and engaging workplace. Our Clayton manufacturing facilities have been honored as a FORTUNE 100 Best Places to Work For 10 years in a row. Other recent employer honors include the ISPE Company of the Year, the Triangle Business Journal Healthiest Employers in the Triangle and the NC Department of Labor 2 Million Hour Safety Award. Approximately 19% of our Clayton employees are veterans, and we offer year-round opportunities to give back to the community. If you're looking for a life-changing career with real impact, join our team and help us defeat diabetes, obesity and other chronic diseases. At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status. Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. Novo Nordisk Clayton NC

Technical Production Specialist/Sr Technical Production Specialist

Grifols Inc.