Job Description
Boehringer Ingelheim’s Ben Venue Laboratories (BVL) is currently seeking a talented and innovativeDirector, Microbiology & Environmental Control to join our Quality Operations department located at our BVL facility in Bedford, OH (Cleveland Metropolitan Area). BVL is a subsidiary of Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI).
If you are not local to the Cleveland Metropolitan Area in the State of Ohio then you must relocate to this area. BVL does have generous relocation benefits for qualified candidates.
Interested candidates should call Tim Whiting directly at 610-263-3030 ext. 4150 and send their resume to tim.whiting@rightthinginc.com as soon as possible.
The Director of Microbiology & Environmental Control is the functional lead of Environmental Control and Microbiology. This position requires specialized knowledge of US and global regulations regarding environmental controls of sterile facilities. This position will interact extensively with the management teams from product development, production, quality assurance, QC chemistry, and validations.
Duties and Responsibilities:
- Functional lead of the Environmental Control and
Microbiology Departments. - Chair of the Environmental Action Committee.
- Chair of the Microbiology / Environmental Control CAPA board
- Stays abreast of developments and advancements in facility
monitoring by attending professional society meetings or by leveraging
knowledge in the BI network to continuously improve site performance. - Lead customer and regulatory compliance audits as they apply
to microbiological testing. - Drive knowledge of aseptic processes and environmental
control throughout the facility. - Drives root cause analysis for environmental and
microbiology investigations. - Trains and develops staff, finds opportunities for career
advancement for all employees. - Oversees sample design and control for environmental control
and microbiology - Participates in and promotes the use of the Quality
Improvement Process available to BVL employees.
Desired Skills & Experience
Required Education and Experience:
- A minimum of a BS degree in Microbiology is required.
Advanced degree is preferred. - A minimum of 8 years of pharmaceutical experience in
microbiology, environmental control, process validations, quality assurance, or
sterile operations is required. - A minimum of 3 years of people management experience in
microbiology or environmental control is required.
Eligibility Requirements:
- Must be legally authorized to work in the United States
without restriction. - Must be willing to submit to a background investigation,
including verification of your past employment, criminal history, and
educational background - Must be willing to take a drug test and post-offer physical
(if required) - Must be 18 years of age or older
Desired Experience, Skills and Abilities:
- Experiential knowledge of Microbiology as well as USP, EP,
JP, Corporate Guidelines, EC Annex 1, ICH guidelines, FDA guidelines.. - Must have good communication skills in order to set
expectations within the department as well as align the department performance
with the performance of all departments that have an impact on the facilities
compliance with SOP's and regulatory agencies.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success.
We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings. Boehringer Ingelheim is an equal opportunity employer. M/F/D/V.
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Email: jobs@aarenconsultants.in
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