Manufacturing Technician II​/III - Upstream​/Downstream (Fri​/Sat​/Sun, 6am-6:30pm

Manufacturing Technician II/III - Upstream/Downstream

Lexington, MA

Genezen is seeking a Manufacturing Technician II/III to play a hands-on-role in the production of clinical and/or commercial cell and gene therapy products, helping our partners deliver life-changing advanced therapies to patients. This role is responsible for performing routine and non-routine manufacturing operations in a cGMP environment, including process execution, in-process controls, equipment operation, and documentation, while working closely with MSAT, QC, QA, Engineering, and Validation teams to ensure safe, compliant, and high-quality manufacturing operations.

The position is Friday/Saturday/Sunday, 6am-6:30pm in our Lexington, MA facility.

Manufacturing Operations

• Execute routine and non-routine production activities according to the manufacturing schedule.
• Follow cGMP requirements, SOPs, batch records, and solution preparation records.
• Use the Enterprise Resource Planning (ERP) system to execute transactions accurately and in real-time.
• Demonstrate and apply aseptic processing techniques.
• Operate in production areas such as, but not limited to, Pre-culture, USP, DSP, buffer preparation, and Fill Finish.
• Perform troubleshooting activities within established procedures.
• Participate in shift handoffs and communicate critical production information.
• Support off-shift, overtime, and holiday production activities as required.

Continuous Improvement

• Identify and communicate opportunities for process, procedural, and operational improvements.
• Participate in continuous improvement initiatives and problem-solving activities.

Documentation & Compliance

• Complete manufacturing documentation accurately and in real time following GDP principles.
• Review batch records, solution records, logbooks, and forms for completeness and accuracy.
• Maintain training compliance and ensure required qualifications remain current.
• Support a safe working environment by identifying and escalating potential safety concerns.

Equipment & Facility Support

• Perform routine equipment cleaning and standardization activities.
• Support product changeovers and manufacturing readiness activities.
• Assist with equipment, process qualification, and validation efforts.
• Conduct facility walkthroughs and maintain manufacturing areas in an inspection-ready state.
• Coordinate equipment and facility issues with Senior and Lead Technicians.

Professional Development

• Maintain an individual development plan and continuously build technical expertise.
• Complete annual self-assessments and actively participate in performance development discussions.
• Demonstrate open-mindedness and self-awareness in receiving and acting upon feedback.

Special Job Requirements

• Adaptability required as work schedule may change based on business needs
• Ability to lift up to 40 lbs
• Criminal background check required
• Other duties as assigned

Education / Certifications / Licenses

• High School, Associates, or Bachelor's Degree, preferably in Life Sciences/Engineering field.

On-the-Job Experience

• 3-8+ years prior manufacturing experience, preferably experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization.
• Hands-on experience in writing and reviewing documentation
• Experience in (bio)-manufacturing unit operations (USP and/or DSP)

Skills / Abilities

• Excellent written, verbal, and interpersonal communication skills with ability to effectively communicate across departments.
• Ability to effectively apply technical expertise and experience to achieve assigned objectives.
• Working knowledge of and adherence to SOPs, Good Documentation Practices (GDP), and applicable regulatory requirements.
• Commitment to maintaining compliance with company internal and regulatory (EMA, FDA) policies, processes and procedures.
• Exceptional attention to detail, strong organizational skills, and a structured, process-driven approach to work.
• Ability to prioritize tasks and manage multiple responsibilities effectively.
• Proactive, self-motivated, and capable of exercising sound judgment and initiative.
• Flexible and adaptable in a rapidly changing manufacturing and development…