Location: Buena, NJ
The Validation Engineer will be 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.
- 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 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.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.