Sr. Associate, Manufacturing- Nights

Job Title: Sr. Associate, Manufacturing- NightsRequisition ID: 119137BRWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.Location/Division Specific InformationLexington, MA- VVSHow will you make an impact?The Manufacturing Sr. Associate is a key assistant and adviser to the Manufacturing Lead and Supervisor and is a direct leader to the manufacturing technicians. In the absence of the Lead the Sr. Associate will assume the role. Sr. Associates are responsible for daily activities required for the GMP manufacturing of clinical and commercial products.What will you do?

Troubleshooting and operating bioprocess manufacturing equipment, aseptic processing, and completing or reviewing the associated documentation of those activities, and monitoring assigned processes using automated production systems and controls.

Keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities.

The Sr. Associate must be technically proficient with a thorough to extensive theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes and have a strong understanding of current GMP and safety standards and be able to apply this knowledge independently in a GMP manufacturing environment.

They will also be a role model and mentor for the manufacturing technicians.

ESSENTIAL JOB FUNCTIONS:Percentage of Time SpentJob Function (In order of %)1) 20%- Prepare and process equipment and materials for manufacturing use including performing equipment functional checks, start up, basic maintenance and operation of single use bioreactors, purification columns and skids.2) 20%- Perform equipment function checks, preventative maintenance, standardization and calibration, and testing of in-process samples using analytical equipment following written procedures. Clean production clean-rooms and remove waste materials.3 )30%- With minimal to no supervision navigate and use with a thorough understanding manufacturing systems for process operation and process performance. Sr. Associates must be able to independently train junior associates on Thermofisher policies, programs and procedures adequately using their experience and knowledge.4) 20%- Assess, author and revise departmental documentation (e.g., Standard Operating Procedures, PBR's and Work Instructions), for GMP compliance, accuracy and completeness. Reviews data, and trends.5) 10%- Participates and runs PPI meetings. Provides input into the investigation of non-conformance's in compliance with procedures, policies and regulations. Write and investigate deviations.POSITION REQUIREMENTS:

Sr. Associate must be able to make process decisions impacting GMP manufacturing including process performance independently with minimal to no supervision. A Sr. Associate must be able to independently recognize, understand, assess, and resolve situations that require additional evaluation or analysis and report these events appropriately.

The Sr. Associate must be able to provide effective written or verbal communication to peers, associates, area management and to all manufacturing support groups.

Sr. Associate must enforce the safe performance of activities and safely perform activities on the shift in order to prevent releases, accidents and injuries.

EDUCATION AND QUALIFICATIONS:

Bachelor's Degree in Life Sciences

2-4 years' industry related experience with a Bachelor's Degree in Life Sciences

3-5 years' industry related experience with a Associates Degree/certificate program

4-6 years industry related experience with a high school diploma

Strong interpersonal and communications skills; written and oral.

Solid understanding of applicable regulatory requirements.

PHYSICAL DEMANDS/FACTORS:While performing the duties of this job, the employee:

Needs Ability to aseptically gown and/or sterile gown as needed

Ability to work within environmental clean rooms

Ability to function in a dynamic environment and balance multiple priorities simultaneously

While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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.Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.