Process Manufacturing Technician II

1 week ago

Milford, Connecticut, United States Rentschler Biopharma Full time

Company Overview

Rentschler Biopharma stands as a prominent global contract development and manufacturing organization (CDMO) specializing in biopharmaceuticals. With our operational bases in Laupheim, Germany, and Milford, MA, USA, we provide comprehensive solutions that encompass bioprocess development and manufacturing, alongside consulting services such as project management and regulatory compliance. Our newly established Rentschler ATMP Ltd. in Stevenage, UK, focuses on advancing cell and gene therapies.

As a family-owned enterprise, we proudly employ around 1100 professionals from 25 different nationalities. Our shared passion drives us at Rentschler Biopharma to empower our clients in their mission to assist patients facing serious or rare health conditions. Through our commitment and expertise, we transform medical research into exceptional biopharmaceutical products, significantly contributing to the global access to vital therapies. To support our ongoing growth, we are expanding our team and invite you to join us on this remarkable journey in shaping the future of biopharmaceutical manufacturing.

Key Responsibilities

  • Execute operations related to commercial scale products, development studies, clinical scale, or validation activities.
  • Operate manufacturing equipment to carry out various production processes.
  • Initiate new revisions for operational procedures as necessary.
  • Demonstrate proficiency in aseptic techniques, including working within a Biological Safety Cabinet (BSC) and sampling.
  • Monitor and document batch parameters, ensuring accurate computer data entry.
  • Complete necessary documentation in compliance with GDP/GMP standards.
  • Troubleshoot process issues and respond to alarms, providing insights for unplanned events and entering data into event management systems.
  • Manage the ordering, receiving, and distribution of supplies within the production area as required.
  • Conduct training sessions for team members, demonstrating procedures and facilitating departmental or process activities.
  • Communicate effectively with external stakeholders, including auditors and global colleagues, and support manufacturing-related groups.
  • Engage in Continuous Improvement Teams to enhance operational efficiency.
  • Perform additional duties as assigned, particularly during production processing.
  • Possess knowledge of laboratory and pharmaceutical production equipment, including autoclaves, process tanks, chromatography systems, and analytical instruments.
  • Utilize standard troubleshooting methodologies, including problem statements and root cause analysis.
  • Undertake other responsibilities as designated by the company.

Qualifications

  • High school diploma with 4+ years of relevant experience or an associate degree in Life Sciences/Engineering; Biotech Certificate preferred.
  • Bachelor's degree typically requires 2+ years of related experience.
  • Proficient in Microsoft Office applications, including Outlook, Word, and Excel.
  • Strong mathematical skills and ability to work with both metric and US measurement standards.
  • Capable of reading and adhering to detailed written instructions with strong verbal and written communication skills.
  • Able to produce legible and grammatically correct documentation.
  • Experience in authoring technical procedures and creating necessary forms.
  • Exhibit good interpersonal skills and work effectively within a team environment.
  • Willingness to meet scheduling requirements, including potential shifts, weekends, holidays, and overtime as dictated by production needs.

Working Conditions

  • Personal Protective Equipment (PPE) must be utilized as required.
  • May involve lifting up to 25 lbs.
  • Manufacturing tasks necessitate remaining on feet for the duration of the shift.
  • Involves pushing buffer containers ranging from 50L to 200L.
  • May require sitting for periods of 2 to 3 hours.
  • Ability to work in a cleanroom environment, adhering to hygiene standards and wearing specialized garments.

Physical Requirements

  • Utilization of PPE as necessary.
  • May require lifting amounts of 25 lbs.
  • Manufacturing operations tasks require operators to remain on their feet for the duration of their shifts.

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