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Under direct supervision of Director Quality Reliability Microbiology the Sr. Manager Microbiology Reliability - Tissue Technology will have supervisory responsibilities. Experience with personnel management complex project leadership and development of junior-level technical employees is preferred.

Responsibilities associated with this Sr. Manager Microbiology Reliability - Tissue Technology (TT) are directly associated with managing personnel that are interpreting microbiological testing data monitoring and maintaining the sterility assurance used in Tissue Technology medical device manufacturing. The candidate must have experience managing as well as interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data tactical planning on a daily basis implementing procedures and remediation projects.

The candidate must be a senior-level professional/team player with advanced knowledge and experience who thrives in a team environment but also has the capability to work alone to research and investigate. An understanding of clean room practice/cGMP and laboratory/GLP environments is required. The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment. This position reports into Global Laboratories Microbiology and Sterility Assurance but will be hybrid and located at an Integra manufacturing site or the corporate headquarters in Princeton NJ.

Qualified candidates must possess relevant experience as a Microbiologist in one or more of the following areas and sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed below.

• Controlled environment monitoring

• Water system monitoring

• Bacterial endotoxin test method validation and monitoring

• Bioburden test method validation and monitoring

• Radiation sterilization validation and dose audit management

• Ethylene oxide sterilization validation and requalification

• Reprocessible device cleaning and sterilization validation

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully an individual must be able to perform each essential duty satisfactorily:

• Support the team in generation and execution of microbial method validation protocols and reports including the review writing routing and approval of summary documentation.

• Design experimental plans to address specific laboratory or testing issues as needed.

• Manage sample/testing processing with onsite and third-party labs ensure timely testing and result reporting.

• Ensure compliance of microbiology procedures validations and records with all company policies and procedures and appropriate regulations including FDA and ISO 9001 ISO 13485 ISO 14644 ISO 14698 BS EN 17141 EU GMP Annex 1 ISO 11135 ISO 11764 ANSI/AAMI ST98 ISO 11137 ISO 11737-1/2/3 ISO 11765 ISO 11138 ANSI/AAMI ST 72and USP.

• Support team members by interpreting microbiological data in order to identify trends and issues that require investigation.

• Contribute to risk management activities including PFMEA generation for various manufacturing locations.

• Scheduling coordination material allocation and alignment of personnel in order to successfully complete project assignments.

• Support the creation of site procedures for microbiological testing and sampling in alignment with validations and in compliance with application regulations.

• Ensure the team is maintaining sustained compliance of manufactured products through the completion of microbial trend analysis investigations change assessment and sterilization process requalifications.

• Mentors non-senior level microbiology staff.

• Support and serve as Microbiology representative on cross-functional teams for transfer NPI and other projects as necessary including supervision of contract resources.

• Ensure that all projects are in compliance with cGMP cGLP QSR (including Design Controls) ISO or other applicable requirements.

• Support and address comments and suggestions associated with sterilization and microbiological test method validations and monitoring procedures.

• Change control non-conformance and CAPA support.

• Support management with providing direction to the team coordinating workflow and providing guidance in the resolution of problems or areas of concern

• Participate in FDA inspections ISO certifications surveillance audits and customer audits.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge skill and/or ability required for this position.

Minimum required education and experience:

• Bachelors degree or equivalent with 8 years of experience Masters degree with 6 years of experience Doctoral degree with 4 years of experience. Bachelors or preferably Master of Science degree in Microbiology or similar discipline. Experience managing multiple teams and results oriented with a strong focus on quality principles.

• Demonstrates excellent team management organizational and communication skills.

• Excellent technical writing skills with an understanding of good documentation practice.

• Experience conducting microbial test method validations and managing projects independently.

• Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products.

• Experience with Controlled Environment Monitoring Water system monitoring compressed air monitoring Bacterial endotoxin test method validation and monitoring Bioburden test method validation and monitoring and radiation sterilization and dose audit management is preferred.

• Working knowledge of applicable microbiology standards including but not limited to ISO 14644 ISO 14698 BS EN 17141 EU GMP Annex 1 ISO 11135 ISO 11764 ANSI/AAMI ST98 ISO 11137 ISO 11737-1/2/3 ISO 11765 ISO 11138 ANSI/AAMI ST 72 and USP.

• Ability to manage teams track milestones and manage projects.

• Working knowledge of applicable regulations and their interpretation within industry.

• Ability to travel up to 30%.

TOOLS AND EQUIPMENT USED

Ability to utilize a computer personal electronic devices as well as other general office equipment. Strong computer skills are required.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this accordance with the Americans with Disabilities Act (ADA) reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position the employee must repeatedly sit listen speak and travel by air train and automobile. The employee will be capable of going to all areas of a medical manufacturing facility including cleanroom areas. The employee may be required to periodically lift and/or move up to 25 lbs.

Salary Pay Range:

Our salary ranges are determined by role level and location. Individual pay is determined by several factors including job-related skills experience and relevant education or training. In addition to base pay employees may be eligible for bonus commission equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire Employees are eligible for the following LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.

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Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency and it must be executed and authorized by the Vice President Talent Acquisition. Where agency agreements are in place introductions (the initial sharing of a candidates name resume or background) are position-specific and may only occur within the scope of that approved agreement. Please no phone calls or emails.

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