Thrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement. If this describes you, then look no further than LSNE. We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices. Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors.
We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!
The Validation Engineer IV performs an array of well-defined validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple facilities. In collaboration with validation management, the engineer provides guidance to internal project teams and external validation firms on large/complex validation/qualification initiatives and ensures project schedules are met. Complies with requirements of the Safety Program, including LSNE Health and Safety mandates and OSHA requirements. In carrying out duties, contributes and promotes a positive and equitable working environment emphasizing the LSNE Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
Author validation plans; oversee and provide direction in the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ Protocols.
Review and approve commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols)
Provide direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment
Work closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project deliverables
Perform a periodic review of systems to monitor the validation status of the system as well as write and develop validation SOPs
Help define validation strategies based on regulations, guidance documents, industry practice and experience
Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation
Team representative on validation projects leading by example on significant projects requiring complex technical solutions
Develop and recommend science-based solutions with a focus on continuous improvement and compliance
Perform risk assessment and mitigation steps to achieve attainment and maintenance of a validated state of compliance for all equipment, utilities, processes, materials, and facilities
Coordinate and execute validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping manager regularly updated
Work in a highly independent fashion, with minimal to no direction in the execution of duties, while keeping team mates and manager informed and providing guidance to other engineers as needed
Write protocols and technical study approaches
Review document changes for validation impact
Review deviation reports for validation impact
Review and approval of change controls
Propose corrective actions to validation manager and appropriate departments and implement the required changes.
Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments.
Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
Direct Validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, master plans, protocols and reports.
Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Sterilization,
Experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes.
Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities.
Possess strong knowledge of commissioning, qualification validation and related practices, including applicable regulations.
Excellent technical writing, verbal communication and presentation skills.
Technical understanding of pharmaceutical/biotechnology unit operations.
Ability to evaluate compliance issues.
Strong skills in team development and leadership
Successful demonstration of collaboration with validation management, and project teams
Proficiency in Microsoft Office including Word, Excel, Power Point, Project
Organized individual who is accustomed to working in a result oriented-focused, dynamic CMO environment
Professional and collaborative team player must have strong interpersonal skills
Honesty, integrity, respect and courtesy with all colleagues
Ability to inspire others to strive for excellence
Self-motivated and able to meet goals with minimal supervision
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Lsne Contract Manufacturing