Lab Leader & Site Microbiologist

Job description

Responsible for developing, implementing and monitoring Quality systems, procedures, and standards for on-going product and initiative delivery at P&G-owned manufacturing sites.. Has direct responsibility for the management of on-site Quality Assurance/Quality Control personnel and product release. Single point of contact for external and internal audits.

Job Qualifications

The Lab Leader and site Microbiologist will have overall responsibility for the development and implementation of the site’s labs and microbiological program in compliance with Company and local regulations:

·  Analytical and Microbiological lab, standards, and procedures; qualification of lab personnel: analysts and advanced analysts, and successors
·  Compliance to the requisites analytical and microbiological operating standards and procedures (GMO SOP system)
·  Risk assessment during Change Control System and Design Reviews processes.
·  Regulatory compliance with cGMPs at the laboratory and the manufacturing facilities and other regulations micro relevant applicable to the site and its customers

The role requires development of technical expertise.

This position will report to the Site QA Leader. In addition, this position should establish links with the assigned global Sector QA Micro Program Leader (Micro QA HPN global leader) and be an active participant of the established global and regional networks.

Prerequisites

The potential candidate must have an appropriate background knowledge in Biological Sciences and the technical capabilities and capacity to guide the site manufacturing operations and work jointly with the Site Engineering team.

Hiring Qualifications could be:

·  BS in Microbiology, including industrial microbiology or experience in the industry
·  BS in Engineering with microbiological qualifications included such as Biotechnology, Food- and Dairy Engineering, Brew master, etc.

General Requirements:

·  The individual must possess a sound technical understanding of analytical and microbiology and their application to industrial processes, operating standards and product testing. If academic background does not support this, the individual should demonstrate technical mastery in industrial microbiology supported by professional experience.
·  The individual will be expected to qualify on the Company’s lab and microbiological qualifications and  SOP’s and standards and able to interpret them correctly and should be able to benchmark site systems with other sites to understand improvement opportunities.
·  The individual should be able to communicate the established metrics for the site micro program.
·  The individual should have intermediate level understanding of Validation.
·  Demonstrated good investigative and documentation skills
·  Demonstrated good understanding of the methods used for product testing, isolation and identification.   
·  They should have a good understanding of the making and packing process to be able to determine where equipment and processes are at risk for microbial contamination
·  The microbiologist will have to develop solid understanding in statistical evaluations to enable data tracking and trending to support quality program and E2E synchronization (i.e., controlled state, parametric release)
·  They must have the authority and confidence to recommend stop or prevent production if significant risks are determined.
·  A good understanding of the regulatory requirements and necessary compliance of the products made at the specific site and the countries where the products will be marketed. Adherence to defined standards at regulatory, corporate and site level.
·  Good communication (oral and written) and, collaboration skills and the ability to network inside and outside the Micro community, globally
·  Demonstrated leadership skills: problem solving; ability to coach leadership in site and sector to provide transparency on micro risks and potential mitigations; influencing skills; to implement required changes across sites and drive improvement
·  The individual should provide necessary information on systems gaps for which the capital is needed and should understand the plant budgeting cycle to work with site QA leader and engineering to incorporate requirements of capital in masterplan.

Job Schedule
Full time

Job Number
R000091294

Job Segmentation
Experienced Professionals (Job Segmentation)

Starting Pay / Salary Range
$85,000.00 - $115,000.00 / year