What are the responsibilities and job description for the Microbiology Technician position at Piramal Enterprises?
Business: Pharma Solution
Department:
Location: Lexington
Job Overview
The Microbiology Technician performs tasks related to the environmental monitoring of facilities and water systems, ensuring adherence to cGMP standards, Standard Operating Procedures, and applicable test methods.
Reporting Structure
Directly reports to EM Supervisor
Key Responsibilities
- Maintain cGMP documentation relevant to the duties and responsibilities assigned for environmental monitoring of the facilities and utilities
- Perform environmental monitoring of classified cleanroom areas
- Assist in the performance and documentation for environmental monitoring of the facilities ,water systems, cleaning verification sample collection and analysis
- Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends
- Participate in Microbiology material inventory control
- Provide support to facility to resolve non-conformance issues and identify corrective and preventative actions as related to environmental monitoring excursions as per PPS QMS systems.
- Maintain laboratory instrumentation required for testing.
- Assist in the review of test data and report any deviations to management
- Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives
- Participate in projects involving the Quality Control and/or Microbiology departments
- Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures
- Perform additional activities assigned by management
Education Requirements
- Bachelor’s Degree in life sciences related discipline is preferred or 1 years equivalent experience is required
Experience
- Experience with common microbiology lab instrumentation including autoclaves, light microscopes, and biohazard safety cabinets.
- Previous work within a laboratory or manufacturing environment is preferred
Competencies
- Working knowledge and practical experience with good laboratory practices and competency with microbiology techniques such as Gram staining, isolation plating, aseptic practice, and microorganism identification methods
- Practical hands on experience with basic lab equipment such as pH meters, balances, water baths and other equipment common to microbiology methods.
- Proficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)
- Understanding of basic lab safety, bio-hazard and chemical waste disposal practices
- Training in cGMP is preferred (may be completed after employment)
Physical Demands
- Ability to wear gowning materials for extended periods of time
- Required to maintain good personal hygiene.
- Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected
- Periodic lifting up to 20 pounds
- Long periods of standing and walking
- Must pass medical clearance to wear a tight-fitting respirator
- Must pass pre-employment physical and drug screen
- The employee may be exposed to materials of potential high potency and/or toxicity in a limited capacity
Work Environment
- This job primarily operates in a high demand laboratory and manufacturing setting, frequently works inside the manufacturing core
- Potential limited exposure to hazardous chemicals
- Position requires working 12 hour shifts, and working on weekends as scheduled
- Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
- Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
