Microbiology Technician

ABOUT US

Pine Pharmaceuticals is a family-owned and operated pharmaceutical company located in Tonawanda, NY along the beautiful Niagara River in the scenic Riverwalk business park. Our team is growing dramatically to meet the tremendous demand for sterile compounded drugs used by physicians every day across the country. Driven by teamwork, Pine is a prominent leader in the 503B outsourcing space, where we continue to innovate.

WHAT IT'S LIKE TO WORK HERE

Pine was founded on a culture of caring, and not just about the specialty coffees available on-campus At Pine, our employees care about each other, about our community, and about the patient who will ultimately receive the drugs we are responsible for compounding every day. There are a lot of perks working for Pine, including regularly catered lunches, employee appreciation programs, generous discretionary bi-annual profit sharing, healthy work-life balance, and much more Above all else, Pine Pharmaceuticals is a family-owned and operated company, and employees are treated just like that. Family

Position Summary:

• Performs various microbiological sampling and testing in an FDA regulated environment.

Essential Functions:

Perform and review environmental monitoring of ISO5/ISO7/ISO8 manufacturing areas (viable air, viable
surface, and non-viable particulate) as well as inspection for compliance.
• Perform and support Media Fill Validations, Engineering Validations and Cleaning Validations.
• Accurate/legible completion of records and documents for tests performed, and accurate computer
data entry/trending/presentation.
• Raw Material/Prefiltration Bioburden/Water sample/Filter integrity testing.
• Media check in and growth promotion.
• Equipment preparation and autoclaving.
• Preparation of microbial ID samples.
• Off testing of incubated environmental monitoring media, testing samples, and Media Fills.
• Use standard laboratory equipment including but not limited to balance, incubator, autoclave, pipettes,
and water bath.
• In-process/finished product sample inspection and submission to in-house/third party laboratories.
• Stocking/ordering lab supplies.
• Assist with revision of microbiology/laboratory procedures and documentation.
• Maintenance of close communication and interaction with QC/QA management.
• Utilization of both Enterprise Resource Planning (ERP) for daily workflow.
• Utilization of a Quality Management System (QMS) for training and document review/ improvements.
• Potential involvement in procedural/policy improvements within the department.
• Support microbiology laboratory investigations including NONC/EE/Issue reviews/OOS/OOT/No
Tests/DIR/CAPA.
• Responsible for promoting and maintaining safe and healthy working conditions in his/her assigned
work area; instructs and enforces compliance with established safe work practices and procedures;
ensures assigned trainees receive appropriate training and information necessary to conduct their
activities in a safe and healthy manner.
• Responsible for cleaning and upkeep of the laboratory and testing areas.
• May perform other duties as qualified/assigned, including but not limited to Sterility ,
Endotoxin , MET testing, NONC issuance.
• Any additional activities as dictated by updates to Standard Operating Procedure and Policies to ensure
compliance with cGMP and regulatory bodies.

Education and Experience:

• A bachelor’s degree (science related field preferred) Other combinations of education and experience
  will be considered.
• None required, however, related experience (working in a microbiology laboratory in an FDA regulated
  biopharmaceutical /medical device industry) is a plus.

Knowledge, Skills and Abilities:

• Must successfully complete training on aseptic gowning procedures and demonstrate the ability to
  aseptically gown upon completion. (required)
  • Accurate/legible completion of records and documents for tests performed, and accurate computer
  data entry. (required)
  • Good time management skills, attention to detail, ability to adhere to implemented standard operating
  procedures/policies, ability to communicate professionally with contract laboratories regarding sample
  testing, communication with others, and flexibility for new opportunities/tasks. (required)
  • Works well independently while maintaining a team-oriented mindset. (required)
  • Experience in microbiological principles and applications related to microbial ID, validation, or clean
  room technology. (preferred)
  • Training in cGMP/cGLP for laboratory operations and compliance to regulatory guidelines with working
  knowledge of environmental monitoring, endotoxin testing, sterility testing, and/or Microbial
  Enumeration testing methods. (preferred)
  • Proficient in the use of standard laboratory equipment including balance, incubator, autoclave, pipettes,
  or water bath. (preferred)
  • Training to ISO, USP or GMPs standards. (preferred)
  • Technology Skills (Windows, Word, Excel, Power Point). (preferred)

Physical Requirements:

• Must have a reliable method of transportation for work travel. (required)
  • Ability to wear high level full body aseptic gowning with face mask for long periods of time. (required)
  • Ability to stand for long periods of time. (required)

Benefits:
• 401K with company match
• Discretionary bi-annual profit sharing
• Health insurance (eligible to enroll on first day of hire)
• Generous vacation/sick time
• Paid holidays
• Positive work/life balance
• Peer recognition program
• Leadership development
• Employee discount at our sister company, Pine Pharmacy