Location: Buena, NJ
Responsible for preparation, execution, and reporting of validation and qualification (IQ/OQ/PQ) deliverables for Semi Solid and Liquid Dosage Pharmaceutical manufacturing including Process, Packaging and Cleaning validation development and monitoring in a cGMP facility. Experience in concepts of qualification of equipment and instrumentation as well as validation of processes.
Reporting Relationships: Individual Contributor
- Participate and support the process validation, equipment qualification, and cleaning validation programs for both sterile and non-sterile processes.
- Develop and execute validation and qualification protocols and reports for the Facility, Manufacturing Processes, Manufacturing Equipment, Packaging Equipment, Packaging Processes, Utilities, and Cleaning Processes for all equipment and products.
- Develop and maintain validation and qualification system level documents including Validation Master Plans.
- Working with Quality Assurance, maintain and administer the change control program for qualification of the equipment and facility.
- Assists in the development of User Requirement Specifications and other relevant facility start-up documentation.
- Provide technical Support to Formulation R&D for scale up and production batches.
- Responsible for Quality reviews and appropriate approval of the documents in compliance with regulatory requirements.
- Support Formulation R&D and technical services teams in executing GMP batches for manufacturing purposes.
- Master’s Degree in Engineering or similar degree with a minimum of 2 years of experience in Pharmaceutical/Medical Device Industry or Bachelor’s degree with a minimum of 5 years of experience in Pharmaceutical/Medical Device Industry.
- Experience in a sterile manufacturing and packaging process validation.
- Experience in Equipment and Facility Qualification in sterile GMP environment; start-up experience strongly preferred.
- Understanding of cGMP’s, FDA, Safety and pharmaceutical industry guidelines.
- Strong technical writing skills.
- Willingness to work as a team and under time/ work pressure.
- Should have excellent verbal communication abilities.
- Good interpersonal, organizational and communication skills (both oral and written) and demonstrated skills in team matrix working. Proven ability to deliver technical reports and presentations.
- Must know MS Office, WORD, and EXCEL, Auto CAD is a plus.
- Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, protocols and final reports.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.