Location: Caguas, PR

Summary:
Provides technical support to Packaging operations for marketed products in a contract manufacturing environment. Responsible for the execution of packaging technical transfer and process validation activities at the site. Provides support to new product introductions, optimizations and validations at the site. Supports product and packaging technology transfer activities ensuring timely completion and process robustness. Carries out activities in all phases of packaging transfer, registration and validation. Supports packaging equipment qualification and cleaning validations efforts at the site. Provides support to periodic review of packaging equipment and processes. Develops and prepares protocols, technical assessments and creates, reviews and updates Packaging Batch Records and Standard Operating Procedures, prepares and obtains approval of validation/qualification technical summary reports. Prepares complaint assessments.

Responsibilities:

• Ensures implementation of packages for new products and revision to existing products.
• Develops and revise test procedures, packaging equipment specifications, labeling specifications, protocols, reports.
• Performs packaging line trials and troubleshooting.
• Leads new packaging technology and product transfers.
• Prepares proofs, makes up samples and approves all necessary mechanical specifications and bill of material (BOMs and BOPs).
• Initiates appropriate packaging stability programs.
• Assesses and investigates customers’ complaints when they apply to packaging.
• Establishes and audits quality standards such as cap torque, seal integrity, etc.
• Participates in initiatives to improve packaging and paperwork flow.
• Reviews documentation related to packaging process to acquire the technical knowledge of products being manufactured and transferred (Pharmaceutical Data Sheet, comprehensive summaries, historical review, validation reports, NDA’s, ANDA’s and Annual Product Reviews).
• Develops, reviews and submits for approval Validation / Qualification Protocols and reports related to packaging processes or related equipment to assure accuracy and compliance with validation protocols.
• Evaluates the process for new or transferred products and, in conjunction with applicable groups, prepares instructions to validate that packaged products are efficient and suitable for stability studies.
• Provides technical support for new technology equipment purchases.
• Identifies problem areas in packaging processes and provides alternative solutions.
• Provides weekly status to TS and Operations Management and interface with the customer, as deem necessary, in relation to on Investigations, CAPAS and Change Requests.
• Conducts complex investigations of packaging problems to determine necessary actions to determine root cause and corrective actions to prevent reoccurrence.
• Performs packaging facility, systems and equipment qualification as well as process and cleaning validation efforts.
• Compiles and issues all applicable documentation.
• Provides technical input for on-the-job training on new or improved packaging processes or equipment.
• Provides consultation to Quality, Manufacturing and Engineering on correct packaging instructions or equipment set up to assure new products/technology comply with all applicable standards. Assists such groups in the preparation or revision of SOP’s and PBRs.
• Reviews and audits validation reports documentation to assure accuracy and compliance with validation protocols.
• Performs assessments for Suppliers Qualification activities for packaging components, as needed.
• Identifies, communicates and implements ideas to improve areas of Operational Equipment Effectiveness.
• Performs other duties as assigned.

Requirements:

• Bachelors Degree in Pharmacy, Engineering or Natural Sciences.
• Three to five years of related packaging experience.
• Expertise in the areas of technology transfer, optimization and validation of packaging pharmaceutical dosage forms.
• Strong analytical skills. Knowledge of regulatory regulations and requirements (GMP, FDA, DEA, OSHA).
• Excellent communication skills in English and Spanish.
• Computer literate, able to present technical information to a diverse audience.
• Flexibility to work non-standard shifts (nights and weekends).

 
 
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: $ 20.14/hr.