Overview

Responsible for QC / Environmental operations, which includes implementing and maintaining appropriate environmental sampling and microbiology testing systems; supervising, training and evaluating personnel; analyzing and interpreting monitoring results; and making appropriate decisions and recommendations to address trends, issues or significant observations. Demonstrates leadership in a fast-paced manufacturing setting and operates with minimal oversight and a clear understanding of business and regulatory demands. Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of biopharmaceutical manufacturing environmental monitoring and testing, and excellent understanding of current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) compliance requirements. Efficiently manages staff and other resources to address scientific, business and regulatory needs in an effective and timely manner. Remains current regarding best practices in environmental monitoring and testing and develops or modifies procedures to stay fully compliant with the evolving expectations of all stakeholders. Formulates strategies for routine monitoring and microbiology testing, prepares protocols and standard operating procedures (SOPs), and reviews and approves work of subordinates. Conducts, schedules and directs monitoring and testing activities, keeping appropriate records consistent with regulatory guidance, business needs and client expectations. Gathers and collates results of environmental testing, identifies trends, interprets implications, and recommends procedural changes to drive improvement. Communicates with Management, Quality Assurance and others as appropriate. Participates in development and implementation of validation plans and protocols. Effectively assists with client and regulatory interactions as appropriate.

Responsibilities

• Responsible for the execution of an Environmental Monitoring program for a biopharmaceutical manufacturing facility, including facility and equipment validation, as well as ongoing monitoring.
• Responsible for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining facility's standards.
• Initiates, prepares, and or approves new protocols, SOPs, Deviations,
• Investigations and other technical documents as directed by management
• Responsible for gathering, collating, interpreting and reporting environmental testing results, and for making sound recommendations based on the results.
• Demonstrates independent scientific technical expertise and programmatic leadership.
• Demonstrates leadership and support of company goals and objectives.
• Conducts critical review of test results and reports data to appropriate internal staff.
• Reports observations of ongoing tests to appropriate internal staff.
• Interacts with pertinent internal departments (e.g. Manufacturing and Quality Assurance) to assure that appropriate testing information is effectively communicated.
• Effectively interacts with clients and/or regulators to address scientific and related issues.
• Interacts with subcontractors (as appropriate) and assumes responsibility to ensure timely and accurate completion of all subcontracted work.
• Initiates, prepares and revises new protocols, SOPs and other technical documents.
• Prepares training materials for tests and techniques.
• Presents technical seminars and provides training on areas of technical expertise and compliance issues relevant to the manufacturing facility or testing laboratories.
• Communicates with supervisor and other colleagues re: daily lab activities.
• Maintains full compliance for areas of responsibility with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
• Maintains accurate records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
• Completes all requisite training (i.e. Bloodborne Pathogen, Quality Assurance, safety, etc.).
• Reviews and authorizes purchase requisitions with sign-off ability as appropriate
• Knowledge and experience in sampling and testing air (e.g., settling plates, RCS), water, surfaces (contact plates, swab samples), solutions, chemicals, materials, and personnel microbial contamination.
• Knowledge of monitoring and testing manufacturing utilities, including air (e.g., Met-One particle counter), water (sampling for USP tests) and clean steam for quality and non-biological contaminants.
• Knowledge of sampling and testing to support studies of cleaning and sterilization efficiency.
• Ability to direct both biological and non-biological testing of environmental samples, and to critically assess and communicate the implications of the testing results.
• Sufficient breadth and experience to implement an effective monitoring program avoiding potential pitfalls, and to appropriately interpret testing results, making sound recommendations and decisions.
• Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work.
• Plans, monitors, and appraises direct reports including performance competencies, goals & job results
• Coaches, counsels, and conducts disciplinary actions
• Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
• Knowledge of cGMP guidelines is required
• Ability to work in a team environment and independently as required
• Maybe required to work Holidays and weekends
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Other duties as assigned
• May be required to assist in other departments
• May be required to work weekends and holidays

Qualifications

• BS/BA in Science related field preferred; or combination of relevant Experience & Education
• 5 years relevant technical experience
• Knowledge of cGMP guidelines is required.
• Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
• Ability to evaluate technical data and write technical documents.
• Ability to use judgment as dictated by complexity of situation.
• Ability to work under limited supervision and to handle problems of a difficult nature.
• Ability to accomplish the described duties through the use of appropriate equipment and software.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Ability to record data accurately and legibly.
• Ability to understand and follow verbal or demonstrated instructions.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)
• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to Lift 20 lbs routinely
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 20 lbs routinely/ often / occasionally
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to climb Ladders / Stairs / Scaffolding
• Ability to work in variable temperatures high to freezing
• Inside/outside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability