GMP Packaging Specialist

The GMP Packaging Specialist works in close collaboration with the Pilot Plant Lead and the extended team to execute project-related scale-up activities. Depending on level of experience, the individual would help support and oversee qualification protocols related to process and cleaning.

The GMP Packaging Specialist is an expert who provides operational support to technical project teams including Richmond Pilot plant and Global Scale Up. Responsibilities range from general material handling, equipment assembly, operation, cleaning, maintenance, and creation and execution of batch records and protocols to support for IQ/OQ/PQ activities and cleaning validation

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

ACCOUNTABILITIES/RESPONSIBILITIES

• Prepares and executes life cycle activities for equipment and systems within the GMP pilot plant (specification, purchase, IQ/OQ/PQ, etc.)
• Coordinates equipment training activities for operators and scientist in the pilot plant

GROWTH MINDSET

• Highlights own training needs and, working with PPL, develops a training plan and achieves training goals
• Trains self and other in new technology and laboratory responsibilities.
• Develops knowledge of regulations impacting areas of work (e.g. EP/USP/ICH, FDA, DEA, OSHA).
• Builds relationships with cross-functional partners to deliver shared goals.

DATA-DRIVEN

• Ensures all work is always conducted following cGDPs and cGXPs.

AGILE

• Takes responsibility for specific equipment in accordance to site procedure.
• Participates and may lead in general problem solving or leads specific problem-solving initiatives.
• Works with key packaging engineers to write User Requirement Specifications, Factory Acceptance Trials, Site Acceptance Trials, Commissioning Protocols, Calibration/Maintenance documents, SOP's updates.
• Coordinate the Haleon approval process for said written documentations.
• Support all the documents that are required to complete validation during the validation process.
• Coordinate other services to complete documentation such as calibration, training, and special assignments.
• Assess packaging documents for correctness and clarity as an entry level engineer.
• Write SOP's that complete/support the commissioning of packaging projects as required.
• Assist in the Computer Maintenance Management System (CMMS).
• Provide high quality work consistent with pharmaceutical standards.
• Maintain accurate documentation.
• Assist in Plant Trials to include writing part of the plant trial.
• Follow Haleon training requirements as well as the Safety, Quality and Compliance programs. 

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Associates degree or technical degree in Pharmaceutical, Engineering or related field, OR Journeyman Card in Mechanics, Industrial Maintenance or related Manufacturing area, OR Military experience with related mechanical maintenance
• Experience in the pharmaceutical, consumer health industry, or manufacturing environment
• Experience in a GMP regulated environment
• Experience in mechanical engineering projects
• Demonstrable experience taking initiative, thinking and working independently, problem-solving and working in teams

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• BS or Technical degree in Pharmaceutical, Engineering or related science
• 5+ years prior experience in the pharmaceutical or consumer health industry
• Experience in manufacturing semi-solid and/or liquid forms
• Experience within Operational Excellence and Lean Six Sigma tools.
• Experience in pilot plants, validation, or engineering
• Experience in packaging
• The ideal candidate would have experience in manufacturing semi-solid and/or liquid forms, and experience within Operational Excellence and Lean Six Sigma tools