We are looking for candidates with familiarity and working knowledge of small scale pressure reactor systems and a mechanical knowledge for replacement of pressure regulators and other piping components. Candidates with experience working in a laboratory setting including, GMP environments, with knowledge of good documentation cGMP; synthetic chemistry; process unit operations; development of procedures and protocols are highly preferred. Experience with reactor processing, assembly, and cleaning per customer SOP’s is highly desirable. Individual may be required to pass respirator fit testing on an annual basis.
- Assistance with production runs on a multi-kilo scale
- Operation and process monitoring of reaction equipment
- Equipment and parts assembly, disassembly, and cleaning
- Execution of equipment commissioning and qualification
- Equipment maintenance and mechanical support for research equipment, including assisting with design and equipment modifications, development and execution of preventative maintenance schedules, review and upkeep of safe operating guidelines
- Maintain good house keeping
- Work in a team environment with scientific staff
- Partner with Research staff and Environmental Health and Safety to ensure safe operations at all times.
- Adhere to all customer cGMP SOP’s
- Responsible for maintaining cGMP logs daily
- Maintain compliance with cGMP training
- Archiving GMP documents
- Provide glass washing and sterilization services maintaining a constant supply of clean and sterile lab glass
- Maintain glass wash statistics as decided upon by Thermo Fisher Scientific and customer and report to management
- Raw material inventory and consumables stocking and control
- Must possess a High School Diploma and preferably an Associate’s degree at minimum.
- Demonstrated verbal, written and presentation skills
- Strong mechanical aptitude; attention to detail; technical problem solving skills; and ability to multi-task.
- Ability to assemble / disassemble, operate and understand equipment per procedures.
- Three to five years of progressive relevant experience preferred.
- Displays a high level of confidentiality for both customer and Thermo Fisher.
- Must maintain Thermo Fisher Scientifics’ Four-I Values.
- Experience in laboratory setting or services preferred; experience in cGMP environment preferred
- Proven excellence in customer service skills.
- Detail oriented, problem solver, promotes team environment.
- Computer/software skills. (Outlook, Excel, Word)
Non-Negotiable Hiring Criteria:
- Must possess a strong desire to serve the customer, and the interpersonal skills to deal with various levels of personnel at the customer site.
- Must deliver excellent customer service to include maintaining a professional appearance at all times.
- Must be proficient with basic computer skills including use of the Microsoft Office suite of software, email, and able to complete training using Computer Based Training (CBT).
- Able to make calculations, and perform the physical tasks associated with drug substance manufacturing expectations
- Have demonstrated initiative in previous work experience.
- Expanded tactical thinking that considers the impact on the broader organization.
- Show concern for well being & success of others.
- Must possess a high level of communication skills to provide guidance to others in performing the work, to effectively present information and respond to questions or customer service requests and interact with various levels of the customer’s organization.
- Must be able to provide suggestions for corrective action and preventive customer service.
- Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics.
- Must be able to apply sound judgment and decision-making skills in dealing with a variety of routine and non-routine issues.
- Works primarily at customer locations, in office environment to include cubicles and/or in and around shipping/receiving docks, stock rooms, storage locations and laboratory environments.
- May be required to work independently at customer location.
- Extensive walking may be required.
- May pass through areas where chemical based allergens may be in use (such as penicillin, tetracycline, etc).
- May be required to wear respirator during certain tasks. Facial hair, such as beards, will not allow a respirator to seal tightly, rendering the respirator useless. Therefore, facial hair shall be shaved during use of a respirator.
- Must be able to lift, push and pull 30-40 pounds consistently; may be required to lift 50 lbs.
- May be able to use material handling equipment such as push carts and pallet jacks.
- Depending on area of building, personal protective equipment may be worn to include lab coats, hairnets and/or safety gloves.
- Some areas require steel toe shoes, bump hats and/or safety glasses.
- Candidates must have an ability and willingness to work overtime hours in support of operations that may include infrequent 24x7 campaigns.