TERM - Sr Manufacturing Associate

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life-saving solutions to
communities around the world.  Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Job Summary - TERM
The Sr Manufacturing Associate role supports the filling of specialty pharmaceutical products and the manufacturing of medical device components which directly contributes to our mission of protecting and enhancing life.

Responsibilities 

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Lives our culture of “right the first time” and ensures quality and accuracy in day-to-day activities
•    Executes and documents procedural steps in compliance with current Good Manufacturing Practices (cGMP) standards and other regulatory requirements
•    Escalates problems, concerns, or deviations in a timely manner
•    Maintain production areas in a tidy, 6 sigma (6S) standard including cleaning and sanitization of work areas
•    Identifies and communicates process improvement and operational excellence initiatives
•    Exercises judgment within defined procedures and practices to determine appropriate action
•    Ability to train others
•    Work in confined spaces

Aseptic Filling

•    Independently prepare and sterilize equipment
•    Independently setup and run the SA25 filler for product filling operations
•    Troubleshooting issues at Engineering user level
•    Run all viable and non-viable samples and independently process samples through the local and LIMS system
•    Perform product transfer and sterile filtration

Manufacturing Medical Device Components (RSDL / ISDTL)

Execute detailed manual and high impact process tasks requiring extensive documentation and interface with automated controls. Process operation involves manual assembly, cleaning, and connections to lobe pumps, nitrogen supply lines, 600 kg inline pressure tank, 500 kg and 2900 kg kettles. Monitoring/adjustment of vessel temperatures, mixer speeds, and nitrogen flow rates during execution to maintain the operational environment. Description of specific requirements include: 
•    Clean large lobe pump, hose lines, mesh screen assembly, 500 kg and 2900 kg kettles, and small parts (clamps, regulators, gasket, etc.)
•    Operate valves, temperature settings, and mixing speed controls using Delta V operating systems
•    Perform in process sampling for PH, conductivity, and finale product samples and work with LIMS system to receive and submit samples
•    Move materials which can weigh more than 36 kgs
•    Work with large and small scales to perform in process dispensing activities.
•    Repeatedly lifting, moving, and adding chemicals to the kettles while wearing required PPE (i.e. half mask respirator)
•    Maintain a state of full gowning (scrubs, mask, safety glasses/goggles, gown, boot covers, gloves, and respirator) for multiple hours at a time.
•    Follow established cleanroom behaviors 
•    Extended time periods of standing, climbing, and bending
•    Working at elevated heights

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills
•    High school Diploma or equivalent is required; Pharmaceutical manufacturing diploma or Bachelors’ degree in Science / Engineering is considered an asset 
•    Minimum of 3 years of related experience is required; Previous experience working in a regulated environment is required
•    Ability to read, understand, and follow standard operating procedures, protocols, work instructions, and other policies/procedures is required
•    Strong written and verbal communication skills
•    Ability to work in a group environment
•    Strong accuracy and attention to detail is a must
•    Knowledge of pharmaceutical regulatory requirements is required
•    Working knowledge of Microsoft Office Suite Products such as Excel, Word, and Outlook
•    Ability to adapt to and complete shift work including days and nights 
•    Ability to lift and move materials/equipment when needed 
•    Ability to pass a pre-employment medical and criminal background check
•    This role requires the removal of all jewelry, wristwatches, make-up and any other non-essential items as per gowning requirements

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.