Senior Associate, Manufacturing
Company: Thermo Fisher Scientific Inc.
Posted on: June 23, 2022
Operates equipment used to manufacture products. Weighs, measures
and checks raw materials to ensure that batches manufactured
contain proper ingredients in proper quantities. (Serves as SME)
Acts as a SME (technical expertise) and demonstrates mastery of
tasks and processes in manufacturing drug product injectables in a
cleanroom environment and following GMP standards. Conduct quality
investigations and support process optimizations. Autonomously run
equipment, pumps, and automated systems and train team members to
ensure it's right the first time and on schedule. Push fluids
through filters in chromatography columns. Set flow paths for the
operations, following SOPs and Batch records and recommending
* Acts as a high-level technician on the floor providing guidance
to other technicians and driving daily operations. Provide critical
evaluation of processes, including foresight and thinking ahead.
Act as a guide to new employees during onboarding process. Has
substantial understanding of the job and applies knowledge and
skills to complete a wide range of tasks.
* High Level Skilled: Aseptic Gowning / material flow, Applicable
processing equipment, SAP/BLV. Works on assignments that are
moderately difficult, requiring judgment in resolving issues or in
* High impact to work. Performs all duties in strict compliance
with Standard Operating Procedures, Good Manufacturing Practices,
Good Laboratory Practices, and Safety guidelines. Maintains the
necessary compliance status required by company and facility
* Stays up to date on required job training. Maintains up to date
training records. Qualified trainer on a complex
* SME or Expert on 1 Unit Operation. Obtains samples of
batches/products in accordance with company procedures; submits
samples to required functional areas for testing and to determine
specific properties. Records/analyzes results and takes appropriate
* Responsible for the upkeep of manufacturing equipment. Recognizes
equipment and product problems, notifies supervisor and/or
troubleshoots errors in order to achieve optimum production
* Review, revise, & author manufacturing batch records. Collaborate
with Quality & PD to review & signoff on executed batch records.
Own the batch record reconciliation. Review, revise, & Author
* Adhere to the Quality Management Systems by living the Quality
values every day and holds peers across the site accountable as
well. Assist with the on-time closure of Nonconformance's/
* Lead PPI initiatives and continuous improvements.
* Identify and communicate items requiring escalation; execute post
escalation decisions. Provide frequent feedback and coaching to
others on ways to improve performance. Receives and checks raw
materials and formulation deliveries and completes appropriate
records in accordance with company procedures
* Active participant of performance huddles and assist supervisors
to plan out and populate process schedules.
* Maintain a culture of safety by identification of near misses,
safety walkthroughs and assisting with resolution of safety
observations. Ensure chemicals are properly stored and labeled.
* 90% of time spent on the floor
* This position will generally require the ability to work a
12-hour rotating shift in a 24-hour, 7 day per week operation to
include evenings and holidays.
* High School Diploma / 3+ years of relevant experience or superior
demonstration of skill sets or background
* Bachelor's Degree in related field / 1+ years of relevant
experience or superior demonstration of skill sets or
Knowledge, skills and Abilities:
Full GMP understanding. Demonstrated ability to lead and mentor.
Understanding of the science behind the process with ability
interpret data and inputs. Strong communication skills (verbal and
written). Good autonomous problem-solving skills. Investigative
skills. Understand cleanroom concepts. Ability to follow directions
& procedures and work in team environment. Strong attention to
detail and drive to accomplish the job timely, accurately and
safely the first time is required, as well as the ability to work
closely and effectively in a team environment. This position will
generally require the ability to work a 12-hour rotating shift in a
24-hour, 7 day per week operation to include evenings and holidays.
Ability to apply knowledge of Good Manufacturing processes and the
knowledge and skills in pharmaceutical processes, equipment,
instrumentation, and procedures. Adhere to all Personal Protective
Equipment (PPE) requirements used within cGMP manufacturing.
Employee is regularly required to stand; use hands to finger,
handle, or feel; reach with hands and arms; sit and to talk or
hear. The employee is required to walk and stoop, or kneel, crouch
approximately 80% of the time. The employee is required to ascend/
descend stairs approximately 20% of the time, lift a maximum of 50
lbs., and sit for a maximum of 4 hours. Specific vision abilities
required by this job include close vision and ability to adjust
focus with tasks.
Keywords: Thermo Fisher Scientific Inc., Providence , Senior Associate, Manufacturing, Other , Plainville, Rhode Island
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