Principal Process Engineer

DSJ Global is currently partnered with an industry leading pharmaceutical manufacturer who is looking to add a Principal Process Engineer to their team in Puerto Rico. The Principle Aseptic Process Engineer is responsible for the design and support of Aseptic Manufacturing, risk management, process validations, equipment qualifications, MVP and any assigned areas to all government regulations, company policies and procedures. This includes supporting planning and execution of key aseptic related projects such as but not limited to: Production process/systems implementation, shut down/restart process, media fill oversight, deviation investigations and change management.

What you'll be doing

• Responsible to ensure timely delivery of assigned programs providing end-to-end quality oversight including but not limited to aseptic process, risk management, MVP, validations process, etc.
• Lead site qualifications and continuous process validations from a quality perspective to ensure requirements are met.
• Provide mentorship and technical expertise of regulatory in Risk Management strategies and processes.
• Assess risks associated with non-conformances complaints, audits, change control etc. and ensure the site process FMEA is evaluated and updated as needed to include new risks.
• Handles activities to maintain site Master Validation Plan.
• Leads the Technical Services team to ensure site validations activities are performed in compliance with regulations and corporate requirements.
• Participates in audits as Subject Matter Expert of the designated areas in addition to encouraging the team to participate in audits.
• Oversee adherence of project milestones to be able to comply with the established projects goals.
• Performs visits to areas of responsibility, document findings and suggestions to improve processes.
• Revises, implements changes and audits existing specifications and SOPs; creates new ones as required.
• Develops and implements procedures on established policies.
• 21 CFR Regulations compliance oriented.
• Safety Regulations OSHA compliance oriented

What you'll bring

• Bachelor's degree (BS) in industrial, mechanical, chemical, or electrical engineering; with at least 5 years of experience in aseptic pharmaceutical manufacturing and/or quality environment.
• Experienced in the manufacturing, handling and testing of Aseptic products, and any of the specific manufacturing technologies used in the site's manufacturing operations, to ensure compliance with cGMP.
• Experience in equipment, process, systems and or computerized systems validation. CQE (desirable). ISO 14644 current version and 21 CFR Regulation Part 210 and 211 or Part 820 (desirable).

• Fully bilingual (written and oral), English and Spanish languages. Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations. Ability to write reports and procedure manuals. Ability to optimally present information and respond to questions from groups of managers, internal or external audits, customers, immediate supervisor, and the general public.
• cGMP's and other training courses, certificates or licenses as per business needs.