Address
Form of workPosition Details:
Our client, a world-leading Pharmaceutical Company in Malvern, PA is currently looking for an Microbiologist III to join their expanding team.
Job Title: Microbiologist III / Pharma Industry
Duration: 12 months contract, extendable up to 24 months
Location: Malvern, PA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Process Microbiologist
This position is responsible for the maintenance of the contamination prevention programs and microbiological hygiene programs.
Candidate will act as a microbiological SME and works with investigators on microbiological contamination issues in the facility and give pragmatic advice to production operators, team leaders and management on topics concerning contamination risk prevention.
Essential Functions:
Provides meaningful input on the aseptic techniques involved in process steps and other areas related to contamination control such as equipment/facility design, cleaning and disinfection, gowning and transport of man and materials into and throughout the facility.
Participates in and supports technical investigations of products or processes
Perform and analyzes environmental monitoring, water system and utility data for trends.
Establishes, documents and escalates risks related to contamination of production processes and products.
Identifies preventative actions related to contamination control that are a result of risk analyses, observations and deviations and ensure implementation by follow up and control.
Maintains a presence on the shop floor where he/she will work closely together with the operators and management of the Manufacturing, and Maintenance departments.
Works closely with other key stakeholders including the QC Microbiology SME, QC personnel, Quality Assurance, Quality Systems, Compliance groups and Operations.
Successfully completes regulatory and job training requirements according to established timelines.
Maintains current knowledge of regulations and industry trends.
Education and/or Experience:
Minimum of a B.S. in Biology, Biochemistry, Microbiology, or a related discipline is required
An MS or PhD in Biology, Biochemistry, Microbiology, or a related discipline is preferred.
Minimum of 6 years of experience is required
Experience with Quality Risk assessments is required.
Requires thorough knowledge of applicable cGMP requirements.
Must have a detailed understanding of Large Molecule production processes and critical process steps in relation to contamination control.
Experience on the shop floor in a pharmaceutical or biotechnological manufacturing environment.
Advanced knowledge and understanding of regulatory requirements, including Safety, QA and QC functions, compliance requirements and experience in regulatory inspections.
Must possess solid knowledge of routine and non-routine environmental testing and sampling methods, techniques, and related equipment.
Language Skills:
Must be able to communicate effectively, clearly and accurately in verbal and written English.
Must be able to write accurate, grammatically correct reports, business correspondence and procedure manuals in English.
Provide effective and timely communication within the department.
Reasoning Ability:
Must be able to read, analyze and interpret general business periodicals, professional journals, technical procedures, governmental regulations, common scientific and technical journals and legal documents, as appropriate.
Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases.
Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems.
Ability to deal with a variety of abstract and concrete variables in situations where only limited standardization exists.
Requires ability to make well balanced decisions, awareness of risks and consequences.
Computer Ability:
Must be able to utilize software and customized programs to meet business needs.
Ability to utilize various standard programs for data entry and word processing.
Mathematical Skills:
Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
Ability to apply mathematical operations to such tasks as frequency distributions, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
Other Skills, Abilities Or Qualifications:
Knowledge of microbiological methods, including endotoxin, bioburden and microbial identification methods.
Biochemical and chemical concepts, theories.
Must be able to effectively don and wear required primary and secondary gowning materials (one-piece jumpsuits, head covers, gloves, overshoes, sterile frocks, etc.).
Ability to deal with large amounts of complex information and often make critical decisions with limited information.
Our client, a world-leading Pharmaceutical Company in Malvern, PA is currently looking for an Microbiologist III to join their expanding team.
Job Title: Microbiologist III / Pharma Industry
Duration: 12 months contract, extendable up to 24 months
Location: Malvern, PA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Process Microbiologist
This position is responsible for the maintenance of the contamination prevention programs and microbiological hygiene programs.
Candidate will act as a microbiological SME and works with investigators on microbiological contamination issues in the facility and give pragmatic advice to production operators, team leaders and management on topics concerning contamination risk prevention.
Essential Functions:
Provides meaningful input on the aseptic techniques involved in process steps and other areas related to contamination control such as equipment/facility design, cleaning and disinfection, gowning and transport of man and materials into and throughout the facility.
Participates in and supports technical investigations of products or processes
Perform and analyzes environmental monitoring, water system and utility data for trends.
Establishes, documents and escalates risks related to contamination of production processes and products.
Identifies preventative actions related to contamination control that are a result of risk analyses, observations and deviations and ensure implementation by follow up and control.
Maintains a presence on the shop floor where he/she will work closely together with the operators and management of the Manufacturing, and Maintenance departments.
Works closely with other key stakeholders including the QC Microbiology SME, QC personnel, Quality Assurance, Quality Systems, Compliance groups and Operations.
Successfully completes regulatory and job training requirements according to established timelines.
Maintains current knowledge of regulations and industry trends.
Education and/or Experience:
Minimum of a B.S. in Biology, Biochemistry, Microbiology, or a related discipline is required
An MS or PhD in Biology, Biochemistry, Microbiology, or a related discipline is preferred.
Minimum of 6 years of experience is required
Experience with Quality Risk assessments is required.
Requires thorough knowledge of applicable cGMP requirements.
Must have a detailed understanding of Large Molecule production processes and critical process steps in relation to contamination control.
Experience on the shop floor in a pharmaceutical or biotechnological manufacturing environment.
Advanced knowledge and understanding of regulatory requirements, including Safety, QA and QC functions, compliance requirements and experience in regulatory inspections.
Must possess solid knowledge of routine and non-routine environmental testing and sampling methods, techniques, and related equipment.
Language Skills:
Must be able to communicate effectively, clearly and accurately in verbal and written English.
Must be able to write accurate, grammatically correct reports, business correspondence and procedure manuals in English.
Provide effective and timely communication within the department.
Reasoning Ability:
Must be able to read, analyze and interpret general business periodicals, professional journals, technical procedures, governmental regulations, common scientific and technical journals and legal documents, as appropriate.
Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases.
Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems.
Ability to deal with a variety of abstract and concrete variables in situations where only limited standardization exists.
Requires ability to make well balanced decisions, awareness of risks and consequences.
Computer Ability:
Must be able to utilize software and customized programs to meet business needs.
Ability to utilize various standard programs for data entry and word processing.
Mathematical Skills:
Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
Ability to apply mathematical operations to such tasks as frequency distributions, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
Other Skills, Abilities Or Qualifications:
Knowledge of microbiological methods, including endotoxin, bioburden and microbial identification methods.
Biochemical and chemical concepts, theories.
Must be able to effectively don and wear required primary and secondary gowning materials (one-piece jumpsuits, head covers, gloves, overshoes, sterile frocks, etc.).
Ability to deal with large amounts of complex information and often make critical decisions with limited information.
