Engineering Jobs in Belgrade, ME

Sterility Assurance Associate – 3-6 Month Contract

We are seeking a Sterility Assurance Associate to support sterility assurance and contamination control initiatives within a biologics manufacturing environment. This role will provide hands-on support and technical guidance to ensure sterile manufacturing operations meet GMP requirements, regulatory expectations, and industry best practices. The associate will collaborate cross-functionally with Manufacturing, Quality Control, and Technical Services teams to strengthen programs including aseptic training, aseptic process simulations (media fills), and environmental monitoring.

Key Responsibilities

• Provide technical support for aseptic processing, contamination control, process validation, and lifecycle documentation.
• Partner with Manufacturing and Quality teams on validation and qualification activities for facilities, equipment, utilities, and processes.
• Author and maintain SOPs, validation plans, and contamination control documentation.
• Support risk assessments, gap assessments, remediation activities, and regulatory inspection readiness.
• Oversee validation and requalification activities, including media fills, sterilization cycles, and aseptic process validations.
• Assist investigations, including root cause analysis and CAPA related to sterility or contamination events.

Required Qualifications

• Bachelor’s degree in Microbiology, Biology, Engineering, or related scientific discipline.
• Knowledge of global GMP and regulatory standards (FDA, EU GMP, etc.).
• Experience supporting sterile or aseptic manufacturing environments.

Preferred Qualifications

• Experience in parenteral, biologics, or vaccine manufacturing.
• Hands-on experience with environmental monitoring, aseptic processing, and sterile gowning practices.
• Experience performing sterile manufacturing risk assessments and remediation initiatives.
• Familiarity with Lean or Six Sigma methodologies.
• Strong organizational and communication skills; able to manage multiple priorities in a fast-paced, regulated environment.

The client is searching for a data-driven and STEM-strong Operations Manager for their Columbus, KS manufacturing facility.

This position offers significant growth potential within the organization and serves as a stepping stone towards becoming the facility's General Manager.

Candidates are required to have at least four years of active duty U.S.

military experience and a bachelor's degree, preferably in a STEM field such as Mechanical Engineering or Chemistry.

Ideal applicants should have skills in AI/ML and SQL, or the ability to work with raw data sets.

The role involves supervising all production-related activities, building teams, conducting interviews, overseeing training, managing production processes, and offering input for product strategy development.

In addition to managing production operations, the Operations Manager will be responsible for establishing and maintaining manufacturing operations, including labor hours, production costs, and quality control standards.

The role requires the development of a comprehensive manufacturing process plan, covering personnel needs, materials, subcontracting, facilities, and tooling.

Utilizing software tools like Microsoft Visio Design, statistical tools such as Minitab, and MS Office are essential.

The manager will frequently use advanced tools such as ChatGPT or other large language models to address plant issues and independently handle cloud-stored operational data.

Delivering monthly performance reports to senior leadership in a presentation format is also a key responsibility.

The clients search is conducted with a commitment to equal employment opportunity, ensuring candidates are considered without discrimination.

Prospective candidates are expected to possess strong analytical skills, demonstrated by their ability to analyze and interpret complex data, and present findings effectively.

Familiarity with Six Sigma methodologies and a consistent track record of driving operational improvements are considered valuable assets for the position.

This role promises a robust career trajectory within a nationwide organization, appealing to candidates with a military background and a data-oriented mindset.