Sr. Principal Engineer – Parenteral Engineering

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Organization Overview :

The Sr. Principal Process Engineer for Parenteral role is a technical position that supports the asset delivery, process development, commissioning, qualification, validation, and startup of the associated processes and equipment in the Parenteral manufacturing area.

The Principal Engineer will lead the areas of equipment prep, formulation, and filling and become the lead SME in the area.

Primary objectives include the start-up and compliant manufacturing of RTP products, particularly as it related to development and implementation of process strategies, partnering with other areas to develop and implement validation strategies, and other related activities.

Responsibilities :

• Provide technical support for all start-up activities related to formulation of drug product, temperature mapping, cleaning and sterilization programs.
• Lead as the site representative during installation, and qualification of the assets related to parenteral expansion.
• Provide input to project schedule and identify project resources needed for on time completion of activities.
• Provide technical support for root cause investigations related to process equipment.
• Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Support during internal and external audits
• Prepare, technical documents, as required, such as : change controls, commissioning and qualification test cases, process changes etc.
• Work within cross-functional teams in a positive fashion to implement Process Engineering objectives.
• Collaborate with and influence partners across the Parenteral Network and teams to ensure harmonization across platform
• Build and drive safety and quality culture within organization.
• Provide technical support in terms of SOP approvals, verification and design documents reviews and approvals, and on-field support as required.
• Ensure equipment is properly maintained in a qualified state for reliable supply of medicine
• Lead and implement continuous improvement projects or troubleshooting initiatives.

Basic Requirements :

• Bachelor's degree in Engineering
• At least 8 years of experience as a lead Engineer in Parenteral drug product manufacturing.
• Previous equipment qualification and process validation experience.
• At least 4 years of experience with aseptic filling process or drug product formulation process.

Additional Skills / Preferences :

• Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, and OSHA.
• Prior experience with regulatory and internal audits.
• Previous experience with highly automated equipment.
• Previous facility or area start up experience.
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• Previous experience with deviation and change management systems including Trackwise.
• Excellent interpersonal, written, and oral communication skills.
• Strong technical aptitude and ability to train and mentor others

Additional Information :

• Ability to work 8-hour days Monday through Friday
• Ability to work overtime as required

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