Senior Specialist, Manufacturing & Research

Senior Specialist, Manufacturing & Research

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

At our Company’s Animal Health campus in Worthington, MN, near Okabena Lake in southwest Minnesota we currently have a Bioprocess Engineer position available within our BTS team (A part of our Company’s Global Technical Operations team).

The successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of vaccine product manufacturing facility.  You will be working with a team of two Technical Operations team members, select manufacturing managers, highly talented shop floor personnel and on-site engineers as well as off-site of our Company global support teams.

Position Responsibilities:

  • Providing technical support for vaccine, biologic, and sterile manufacturing processes in the form of data analysis, troubleshooting, problem-solving, report writing.
  • Ensure seamless and rapid technology transfers from Upstream Process Development through the review of upstream technology transfer protocols and participation on project development teams
  • Supporting change control implementation for manufacturing.
  • Support Lyophilization processes within group as well as Production.
  • Learning new processes and procedures.
  • Recommending, creating, writing process control and automation instructions.
  • Performing off-shift work (only as needed).
  • Conducting technical investigations and analyses.  Investigate selected process non-conformances (OOS) and deviations, review and troubleshoot with the help of the team and set CAPA’s.
  • Recommending and implementing corrective and preventative actions and helping lead reduction of atypical events for the area.
  • Provide technical support for site Capital projects.
  • Writing, reviewing, and improving procedures for operation of equipment and processes.
  • Contributing to process and equipment safety reviews.

Education Minimum Requirement:

  • B.S. degree in scientific or engineering.

Required Experience and Skills:

  • Minimum 5 years post-bachelor’s degree experience in USDA 9CFR or GMP manufacturing and/or technical support of USDA 9CFR or GMP manufacturing operations (or M.S. degree plus 3 years; or PhD degree).
  • Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills.
  • Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, ergonomic risks, ability to automate processes).
  • Understanding of strategic planning and resource management.
  • Experience working in cross-functional teams leading projects.

Key Competencies include:

  • Demonstrate a working knowledge of biologics production processes and associated equipment.
  • Apply knowledge to streamline production processes and minimize downtime.
  • Understand and incorporate relevant GMPs.
  • Work with site leadership to develop and execute the growth strategy.
  • Ability to prepare and present proposed solutions to stakeholders through clear communication and effective meeting management skills.

Preferred Experience and Skills:

  • Advanced degree (M.S., PhD) in science or engineering (Chemical/Biochemical).
  • Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
  • Six Sigma and/or Lean certification.
  • Regulatory inspection presentation experience with external regulatory authority representatives.
  • Thorough understanding of basic statistical tools for process data analysis.
  • Desire to be part of a team and work together to solve complex issues.
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in a team environment.
  • Project Management experience including use of Microsoft Project™, Risk Communication and Escalation and project status communication.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

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Posted on

December 16, 2021