Location: Manati, PR
Shifts: Administrative Shift (8:00am - 5:00pm, Off hours, availability on weekend and holiday, if needed).
Project Duration: 12 Months

Job Purpose:
Accountable for the design and execution of IQ/OQ/PQ studies of process for parenteral and oral solid drug dosages products manufactured at company. Accountable for designing and executing qualification studies for sterilization/Depyrogenation/bio-decontamination equipment (autoclaves & SIP, tunnel, Isolator), utilities and facilities to support their effectiveness in the manufacture of parenteral/oral solid drug dosages products. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required for the job function.

Responsibilities:

• Conducts process/packaging equipment installation/operational/performance qualification studies to test their functionality for the manufacture of parenteral and OSD products.
• Conducts critical sterilization/Depyrogenation/bio-decontamination equipment (tanks, autoclaves & SIP, tunnel, isolator), utilities and facilities qualification studies (Critical utilities/systems includes Purified Water, HVAC, compressed gases) to ensure that a system functions as to routinely produce results that meet predetermined specifications.
• Conducts temperature/relative humidity mapping qualification studies (cold boxes, freezers, and incubators) to ensure that a system functions as to routinely produce results that meet predetermined specifications.
• Prepares operational qualification assessments to support that validated critical operating parameters are within qualified parameters for specific parenteral and OSD products. Identify and evaluate equipment enhancements to support intended qualified operational ranges.
• Hands on experience in the use/troubleshooting of validation equipment such as KAYE Validator, thermocouples and temperature/relative humidity data loggers.
• Supports the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.
• Supports process capability and statistical analysis related to equipment performance within parenteral and OSD manufacturing process
• Serves as Subject Matter Expert for qualifications during regulatory audits (internal and external).
• Supports the periodic review of equipment/system qualifications studies.
• Assists and performs as the liaison person with the Information Technology Department in the implementation and qualification of upgraded equipment control systems and automation initiatives.
• Prepares well-documented protocols for all equipment/utilities qualification exercises in compliance with corporate guidelines, procedures, FDA Regulations and industry current practices.
• Executes and ensures successful and timely equipment/utilities qualification activities as per established protocol in support of the manufacturing operation at the site.
• Executes activities according to the Time and Event schedule developed by the site team.
• Performs in process test as required, analyze qualification data and generate conclusions based on test results and reports the results in an accurate and timely manner.
• Performs successful and on time resolution of incidents and deviations related to equipment/utilities qualification exercises.
• Proposes and formalizes alternatives for enhancement of site qualification program.
• Investigates and conducts troubleshooting and root-cause analysis of unexpected trends or results during equipment/utilities qualification activities, implements accurate and timely solutions and; develop and manage plans as needed.
• Evaluates deviations with respect to their causes and corrective actions to prevent recurrence.
• Identifies, plans, and implements quality and productivity initiatives associated to equipment/utilities qualification activities based on business needs and priorities.
• Assures the accuracy and correctness of documentation used during equipment/utilities qualification activities.
• Trains manufacturing and QC/QA personnel on the qualification documentation.
• Assures compliance to corporate guidelines and site procedures governing overall operation.
• Maintains documentation in accordance with cGMP and FDA regulations.
• Maintains equipment/utilities qualification program in conformance with department standards and government/corporate regulations.

Minimum Requirements:

• Bachelor Degree in Pharmacy, Chemistry or Engineering.
• Five (5) years of experience in a pharmaceutical industry with at least three (3) years in solid oral dosage forms.
• Proficient technical knowledge/expertise in pharmaceutical manufacturing processes/technologies and processing equipment for oral dosage forms, including packaging technologies.
• Proficient knowledge of equipment/utilities qualification, continuous process improvement and troubleshooting processes.
• Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways to equipment/utilities qualification.
• Strong project management skills.
• Proficient time management skills, planning and organization capabilities.
• Proven ability to influence and work with people at different levels and departments.
• Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups.

Notes:

• Responsibilities and Accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description.
• This position will require the employee to work with chemical, radiological or biological agents that may be hazardous to health if mishandled (including agents who made potentially affect reproduction or the fetus or nursing infants). Employees will be required to follow all safety procedures and use personal protective clothing/equipment where specified.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 52.51/hr.