Manufacturing Technician II - Formulation (Nights)

Job Responsibilities

Operations

• Perform start-up, equipment operation, batch execution, material handling, cleaning, housekeeping, and line clearance activities as required to maintain a cGMP environment.
• Work collaboratively with mechanic technicians and lead technicians to resolve production-related issues such as batch set-up, execution, documentation, equipment operations, SOPs, and safety and quality inspection procedures.
• Monitor process execution, material, and supply levels to ensure successful operations on the production floor; coordinate production tasks such as batch execution.
• Perform clean in place and steam in place of process lines per SOPs.
• Perform, set up, and create single-use connections including single-use bags.
• Perform and execute filter integrity testing as needed per SOP.
• Perform parts washing and dispensing operations as necessary.
• Assemble, disassemble, and sanitize equipment.
• Operate automated and semi-automated equipment (pumps, mixers, etc.).
• Assist technical staff with preventive maintenance procedures as required.
• Support lean activities including 5S, problem-solving, process improvement analysis, and manual tracking of performance data for OEE data tracking.
• Perform inventory control using SAP.

Documentation & Compliance

• Complete batch record and GMP documentation entries, including mathematical computations.
• Follow job-related safety procedures including PPEs, LOTO, ergonomics, material handling, chemical/waste/spill controls, and human safety.
• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures and OSHA requirements and guidelines; report all discrepancies to process facilitators.

Training & Development

• Acquire and maintain all required certifications and qualifications for the assigned work area.
• Cross-train and support other work areas as needed.
• Attend and actively participate in daily tier meetings.

Experience & Education

Minimum Qualifications

• Prior experience in a regulated manufacturing environment.
• Working knowledge of automated and semi-automated equipment (pumps, mixers, etc.) as well as light material handling equipment.
• Ability to effectively read, write, speak, and understand English to follow detailed instructions and communicate with team members.
• Demonstrated attention to detail with the ability to accurately complete batch records, logbooks, and other controlled documentation.
• Basic problem solving and mathematical skills, including the ability to perform routine calculations (e.g., weights, measures, conversions).
• Ability to follow SOPs, written procedures and work instructions with minimal supervision, escalating issues as needed.
• Ability to identify deviations or inconsistencies in processes or documentation.
• Ability to work effectively as part of a team in a fast-paced production environment.

Preferred Qualifications

• High school graduate, vocational school graduate, or equivalent.
• 1+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Working knowledge of cGMP principles, including documentation practices, safety procedures, and compliance expectations.
• Experience working in a lean manufacturing environment.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.

Physical & Work Environment

• This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
• Visual acuity such as working with data & figures, viewing computer terminals, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.
• Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.
• Ability to pass eye exam during onboarding.

Work Schedule

12 hour nights – 2/2/3 rotating schedule. The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.