The validation department performs validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing.
An exciting opportunity has arisen for a Sr. Engineer to support Tech Transfers/ New Product Introductions (NPI) within the Aseptic Process Validation team.
The Validation team at the clients site consists of three sub teams - Aseptic Processing Validation, Equipment Validation & Cleaning Validation which together manage the qualification program for the introduction of new products to site or life cycle changes to existing products.
The Validation NPI Engineer will support new product introductions from a Validation perspective and serve as the Validation SME for each new product transferred. The processes involved may be formulation, filling (vials & syringes), automated inspection and/or packaging for parenteral products. The completed Validation package will ultimately support the regulatory filing for that product at the clients site.
The activities of the Validation Sr. Engineer - NPI are to:
· Author and review regulatory documents (Section P.3.5)
· Provide technical input to assess validation impact to all the changes required for the new product/process.
· Act as a responsible point of contact for the transfer project for Validation on the cross functional team.
· Participate in full lifecycle of Product transfer:
- Attend Make a Batch reviews and provide validation input.
- Change Control Assessments: attend Stakeholder meetings, complete GDE documentation for validation team,
- Develop, review and approve Validation plans protocols and reports
- Execute Validation studies, document and investigate any discrepancies raised.
- Support MES/EBR updates
- Support regulatory filings and RTQ's for validation as required.
· Ensure Validation approach is based on the best available scientific evidence and professional judgment in collaboration with the Validation team. Support a robust fit for purpose transfer with quality designed into the process.
· Assist with trouble shooting the equipment and advise cross-functional team on best qualification strategy. Strong judgment is required in resolving problems and making recommendations.
· Develop and ensure internal policies, procedures and practices associated with the transfer are in compliance with Validation procedures.
· Ensure projects are executed safely, efficiently, and in accordance with all applicable codes and the clients Standards.
Basic Qualifications:
· Master's degree with 5+ years of experience in validation, engineering
Or
· BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality
Preferred Qualifications:
· In-depth understanding and application of validation principles, concepts, practices, and standards.
· In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing
· Extensive working knowledge of sterilisation/decontamination systems and industry practices.
· Experience with Aseptic Process Simulation/Media Fill
· Experience in Technical writing and translating complex process data, validation reports, and control strategies into clear, regulatory-compliant narratives.
· Demonstrate active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution
· Demonstrate ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
· Strong program and change management skills
· Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
· Comfortable in a fast-paced, dynamic, and highly fluid company environment with works under consultative direction toward pre-determined long-range goals and objectives.
· Able to adjust workload based upon changing priorities
· Previous people management experience highly desired.
· Able to express ideas and present information effectively to the clients leadership, within team functions, and with external partners
· Ability to think critically with demonstrated troubleshooting and analytical skills
