Work Schedule
First Shift (Days)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cold Room/Freezers -22degreesF/-6degrees C Fluctuating Temps hot/cold Laboratory Setting Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) Warehouse Working at heightsJob Description
This is a fully onsite role basedatour GMP Lab in Middleton WI. We welcome applicants from all locations within the US.Please note that relocation assistance is not provided for this position and any relocation costs will be the responsibility of the candidate.
Must be legally authorized to work in the United States withoutsponsorship.
Must be able to pass a comprehensive background check whichincludes a drug screening.
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists industry thought-leaders and therapeutic experts. As the world leader in serving science our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations
Summary:
Provides maintenance on various laboratory instrumentation and equipment. Maintenance includes installation routine and remedial maintenance calibration and/or qualification and at times troubleshoots. Work is performed independently and documented in accordance with standard operating procedures and established maintenance schedules to meet regulatory requirements. Works with lab staff and schedules maintenance and trains others on equipment as needed. Trains mentors and provides oversight to junior level staff responsible for the same tasks.
Responsibilities:
Performs scheduled maintenance on active instrumentation and equipment.
Performs scheduled calibrations/qualifications on active instrumentation and equipment to include IQ (Installation Qualification) OQ (Operational Qualification) and PQ (Performance Qualification).
Independently writes and reviews qualification documentation. Performs remedial maintenance on active instrumentation and equipment and problem solves issues.
Oversees and manages installation of new laboratory instrumentation and equipment.
Trains end users on existing instrumentation and equipment as required.
Prepares SOPs pertaining to operation maintenance and calibration of laboratory instrumentation and equipment.
Addresses audits on laboratory instruments and equipment. Evaluates lab support records for compliance with SOPs reviews for completeness and accuracy and reports findings.
Education and Experience:
Bachelors degree in engineering or science field or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2-5 years). In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills and Abilities:
Understanding of FDA and GMP regulations and requirements
Knowledge and understanding of laboratory instrumentation and equipment
Working knowledge with systems within the CRO/Pharmaceutical industry
Troubleshooting analytical and problem-solving skills
Client focused approach with strong interpersonal skills
Ability to communicate effectively with vendors clients and all levels of staff
Ability to work in a collaborative team environment
Emphasis for this role is to engage alongside the support group and meet business needs for REES Environmental monitoring new equipment qualification and temperature distribution mapping.
This role requires occasional on-call availability.
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
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 100000 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 with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.
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.
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-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes such as not being able to get into the career website following up on an application or other non-disability related technical issues will not receive a response.
Required Experience:
Senior IC
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