Senior Validation Engineer※CMIC CMO USA

シミックグループは、日本初のCRO（Contract Research Organization：医薬品開発受託機関）として創業して以降、自由な発想と先見性で、製薬業界の中で製造や販売に至るまで様々な新しいサービスを生み出してきました。

現在においては、製薬業界に留まらず、ヘルスケア業界に向けたビジネスの展開も進めており、各プロフェッショナル人材の活躍の場が広がっています。

RESPONSIBILITIES OF ROLE

Coordinates with Production, Quality, Maintenance, and other personnel as needed to manage projects, capacity increases, and process improvements.  Plan, manage, and execute the start-up, commissioning, and validation of new or modified equipment trains to create company cleaning and process validation master plans, and other projects.  Writes and executes validation protocols, such as Installation, Operational, and Performance Qualifications (IOPQs), and Utilities Qualification.  Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards. Coordinates Validation Program activities in compliance with CMIC policy and department, local procedures and regulatory expectations.

PRINCIPAL DUTIES OVERVIEW
·       Develop qualifications and retirement documentation.
·       Conducts field execution of validation deliverables, resolve any deviations, and author reports.
·       Assists in maintaining validation process  improvement projects
·       Authors/reviews/updates appropriate SOPs.
·       Follows pharmaceutical industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications, and requirement specifications.
·       Works within cross-functional teams and communicate progress effectively to other team members and validation management.
·       Ensures process and project documentation is accurate and updated.
·       Maintains safe working environment.
·       Ensures that all activities are in compliance with cGMP, Health Authority regulations and the CMIC policy.
·       Supports 3rd party validation activities, where applicable.
·       Completes assigned validation projects in timely manner.
·       Maintains and improves job knowledge by remaining current in industry trends, attending educational seminars, reading professional publications and participating in professional organizations.
·       Performs other special projects and duties as assigned by department management.

TECHNICAL KNOWLEDGE
·        Candidates should have experience in qualification and process validation.
·        Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ/PQ protocols and final reports.

QUALIFICATIONS
· Education & Experience
· Master’s degree in Pharmaceutical Science or Engineering field required or Bachelor’s degree with at least 7 years of experience.
· 3 to 6 years of experience in Pharmaceuticals industries.
 
· Knowledge/Skills
· The ability to work successfully in both a team/matrix environment as well as independenly.
· The ability to work in a fast paced environment, manage priorities and maintain timelines for multiple projects.
·Ability to utilize Microsoft Word, Excel and Visio, excellent word processing skills

· Cognitive Requirements  
·Ability to read, write, communicate and handle stress produced by time pressure, customer demands, etc.

· Physical Requirements
·Must be able to access all laboratory, manufacturing, and office areas.   Must be able to wear the required PPR, for entering laboratory and processing area. Specific vision requires include reading of written documents and use of a computer. Must be able to sit or stand for prolonged periods of time, and occasionally lift up to 25 lbs. with or without assistance.

· Licenses & Certifications
· N/A

Responsibilities and duties are not limited to this Job Description. The employee is expected to follow other instructions and perform other duties requested by the immediate supervisor or company management.  The level of involvement may vary based on company need and individual capabilities.

Worksite Location - Cranbury, NJ, US office

Interested parties, please contact:
Name :Khalida Aftab 
Email: khalida-aftab.ka@cmiccmousa.com