Process Validation Senior Engineer

Pioneer, Singapore

Job Description


When you\xe2\x80\x99re part of the team at Thermo Fisher Scientific, you\xe2\x80\x99ll do important work. Surrounded by collaborative colleagues, you\xe2\x80\x99ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world. Location/Division Specific Information Singapore - Gul Circle What will you do? You will be part of a team of process and equipment engineers and will support all aspects of validation including developing testing protocols, supporting execution activities, and developing validation reports. Responsibilities include some of the following;

  • Develops and implements Validation and Qualification Protocols with a focus on process and material changes, software applications and enterprise systems with minimal supervision.
  • Authors Validation and Qualification Reports summarizing the results of protocol field execution activities with minimal supervision.
  • Supports troubleshooting of equipment and system as needed to address unsuccessful validation testing.
  • Manage deviations that occurs during validation or deviations impacting validated status: bring expertise and help in investigating and solving issues and associated CAPA.
  • Collaborate with Manufacturing Operation, Technical Operation, and Quality Assurance, as well as others, to coordinate and complete validation activities in a timely manner.
  • Provide validation compliance guidance based on standard methodologies and current policies.
  • Perform validation activities associated with change controls.
  • Attends and comply with regular safety and GMP training.
  • Maintains accurate and complete safety and GMP records consistent with company policy and legal requirements.
  • Recognizes potential safety and compliance problems and takes action to rectify them.
  • Maintains validation equipment and instrumentation in accordance with company policy requirements.
  • Writes investigation reports and updates procedures with minimal supervision
How will you get here? Education Minimum bachelor\xe2\x80\x99s degree in Engineering or Science related degree from an accredited university. (Engineering degree is preferred.) Experience Minimum 5 years\xe2\x80\x99 experience, with preference in pharmaceutical, life sciences and/or semiconductors industry. Experience in validation/ QA validation is a requirement Experience in process validation Exposure to ISO13485:2016 environment Knowledge, Skills, Abilities Systematic problem-solving approach. High fluency in spoken and written English. Good organizational and project management skill. Effective problem solving, decision making and analytical skills. Proactive and have the initiative to drive and get things done ahead of plan Strong communication skills. Proven ability to communicate effectively with different departments. Proven ability to work multi-functional teams and projects to obtain desired business objectives Knowledge, Skills, Abilities Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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Job Detail

  • Job Id
    JD1309744
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Pioneer, Singapore
  • Education
    Not mentioned