Location: New York (Hybrid Onsite)
Experience Level: 3-6 Years of Relevant Experience
Position Overview:
We are seeking a skilled Engineering Maintenance Support Engineer to join our team. The ideal candidate will have 3-6 years of experience, a strong understanding of aseptic filling, auto-injector assembly, and packaging processes in biotechnology. This role will be pivotal in ensuring smooth manufacturing processes, including dispensing, preparation, formulation, aseptic filling, labeling, and packaging.
Key Responsibilities:
- Operate and maintain both manual and highly automated filling line equipment with isolator technology for formulation, preparation, assembly, and packaging.
- Handle fully automated assembly, packaging, and labeling lines, ensuring adherence to applicable procedures.
- Monitor Track and Trace systems on packaging lines, performing line clearance and cleaning activities.
- Assist with environmental monitoring and product sampling as per QC guidelines.
- Ensure batch records, logbooks, and processes adhere to cGMP standards and internal procedures.
- Help develop and implement new procedures for cGMP production.
- Create, revise, and execute batch records within the electronic record system (MES).
- Ensure readiness and stock of essential equipment and components.
- Perform troubleshooting and support investigations of equipment failures.
- Participate in equipment start-up, commissioning, and validation.
- Train and mentor colleagues and new employees as needed.
- Travel domestically and internationally for equipment purchase and training.
Required Skills & Qualifications:
- Technical Aptitude: Strong understanding of aseptic processing, filling, and packaging.
- cGMP Knowledge: Experience in a cGMP manufacturing environment, including aseptic techniques and working with parenteral products (vials, syringes, cartridges).
- Team-Oriented: Ability to work collaboratively in cross-functional teams with excellent interpersonal and communication skills.
- Problem-Solving: Strong analytical skills with the ability to troubleshoot and resolve issues efficiently.
- Education: Bachelor’s degree in Life Sciences, Biological Sciences, or equivalent experience. An Associate’s degree/certificate in Biotechnology is also acceptable.
Physical Requirements:
- Must be able to lift/push/pull at least 40 lbs.
This position offers the opportunity to work in a dynamic, fast-paced environment. You will be an integral part of a team ensuring the safe and effective production of vital medical products.
Join us and contribute to life-saving innovations in the biotech industry!
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law, including disability/veteran status. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.