Job Summary
As a Manufacturing Process Technician, you will play a crucial role in the sterile production of innovative treatments for patients with Rare Diseases. Working in a highly controlled environment, you will contribute to manufacturing processes, quality assurance, and continuous improvement initiatives, ensuring adherence to current Good Manufacturing Practices (cGMPs). Your efforts will directly support the development and delivery of life-changing therapeutics.
Key Responsibilities
* Manufacturing Area Duties:
o Perform all activities related to sterile manufacturing, including aseptic filling, drug substance formulation, and preparation activities.
o Execute tasks such as sterile filling, product and component reconciliation, and set-up/breakdown of single-use materials.
o Manage materials handling, weighing, dispensing, and formulation processes.
o Collect, process, store, and deliver samples as per procedural requirements.
o Conduct manual and automated cleaning of equipment and parts.
* Documentation and Compliance:
o Strictly adhere to cGMP standards and accurately complete all process-associated documentation.
o Perform calculations related to manufacturing tasks and ensure proper record-keeping.
o Identify and report malfunctions while maintaining compliance with written procedures.
* Collaboration and Continuous Improvement:
o Collaborate with cross-functional teams to support batch release, material processing, and audits.
o Participate in continuous improvement initiatives to optimize processes and operations.
Qualifications and Skills
* Preferred Qualifications:
o 3+ years of experience in a GMP or other regulated environment.
o Demonstrated knowledge and application of GMP principles.
o Experience in drug product manufacturing is advantageous.
o Proficiency in operating and understanding moderately complex equipment.
o Ability to document tasks accurately and follow detailed written procedures.
* Personal Attributes:
o Strong focus and attention to detail, with the ability to maintain consistency during repetitive tasks.
o Proven ability to work effectively as an individual and within a team environment.
o Coachable and open to feedback, with the capacity for measurable improvement.
o Flexibility to adapt to new challenges and evolving market demands.
o Strong communication skills, technical creativity, and a proactive approach to problem-solving.