Horario-Schedule-3er turno- 10pm.- 630am.

Key Responsibilities
1. Perform mechanical evaluation and troubleshooting

• Performs initial evaluation and minortroubleshooting diagnosis of manufacturing equipment e failures.

• Supports maintenance personnel in major troubleshooting diagnosis activities.

2. Performs complex and highly technical manufacturing operations of aseptic processing and/or isolator technology such as Diafiltration and Concentration of Proteins, Formulation of Proteins, Filling of Proteins in syringes and Vials within Isolators / Barrier Systems or in aseptic area / Barrier Systems or process, Lyophilization process with Automatic Loading within loading Lyophilizers on aseptic environment, Clean in Place (CIP) and Steam in Place (SIP) process in different systems, Decontamination of Barrier System with Vapor Hydrogen Peroxide (VHP), Sterilization cycles with Steam Autoclaves and Dry Heat Ovens and Tunnels, and gloves leak test.

• Operates in an efficient manner of the manufacturing processes to maximize product yield of products.

• Monitors critical process parameters and proactively takes necessary action to prevent process deviation and/or product losses.

• Maintains housekeeping within controls and aseptic environments, according to procedures.

• Handle Hazardous and Non hazardous waste according to EHS procedures.

• Receives, verifies and maintains all production records and transaction documents and in compliance with established procedures including computer generate transactions.

• Receives, handle, verifies and weights excipients, drug substances, and/or active ingredients Performs systems integrity test such as isolators, ultra filtration skid, distribution systems, Percentage of time 30% 55% error free filters and gloves as required.

• Verify calibration status of critical instruments before process operation.

• Complete production documentation legible, error free and on time following good documentation practices.

3. Performs other duties to support other functional areas such as:

• Assist manufacturing activities in other areas within operations as required.

• Initiates, participates, and assists in resolution of quality investigations

• Audits batch records and documentation, as required.

• Revises and improves procedures and develops new SOPs based on observations and experiences.

• Participates in special projects, during audits and regulatory inspections as required.

• Participates and assists in area validation and qualification activities.

• Supports the Annual Requalification Program by assuring plan execution on established timeframe 4.

• Attends to all mandatory training meetings for EHS and Company Policies.

Qualifications & Experience
EDUCATION/ EXPERIENCE:

• Associate degree in a technical field with seven (7) years of experience in the pharmaceutical field or, Bachelor Degree with five (5) years experience in a Parenteral Manufacturing /Finishing in the Pharmaceutical Industry or Isolation technology.

• Basic writing skills when completing area documentation.

• Ability to troubleshoot equipment problems and provide resolutions using appropriate problem solving methodology.

• Basic knowledge on Computerized, PLC control equipment, procedures and new scientific processes and how to troubleshoot them.

• Ability to work with minimum supervision.

• Ability to provide job training, theoretical and/or On the Job, for new employees following the Parenteral Operations Department Qualification Curriculum.

• Knowledge on critical process parameters and their impact in product Knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization and isolators technology.

• Understanding of Process Equipment set-up and able to perform it repeatedly and according to SOPs.

• Ability to apply critical thinking to resolve complex issues and day-to-day situations.

• Excellent leadership characteristics, accountability and commitment.

• Ability to read, write, comprehend detailed technical information and directions and read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.)

• Team player and collaborating skills Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.

• Functional and basic technical knowledge of complex and automated equipment (computer, or PLC control) operation and troubleshoot using the interface systems.

• Skill in performing detailed tasks and documenting information.

• Ability to enter data into a computer and perform complex process transactions.

• Skill in accurate visual inspection for set-up, product and components defects).

• Skill in basic mathematical applications.

• Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).

• Ability to relate and convert from metric to/from English units Ability to plan and/or follows work schedules, set priorities Strong organizational skills.

• Able to wear sterile gowns, mask, and full face respirators and able to use Full Face Mask, Latex/Nitrile Gloves, and disposable uniforms on a daily basis.

• Willing to work irregular hours, rotative shifts, weekends and holidays when necessary.

• Ability to operate pallet jack