What are the responsibilities and job description for the Facility Manager - IMCPL position at University of Pittsburgh?
Directs daily laboratory operations of a division, department, function, or program. Conducts and manages quality assurance and quality control and instructs staff on quality control and analytical procedures. Develops complex design projects and laboratory procedures and evaluates new products. Writes grant applications and manuscripts independently. Ensures compliance with all applicable regulations.
Health Sciences Core Research Facilities
This Facility Manager ensures that all processes and systems related to drug product release remain in a validated state, adhering to current Good Manufacturing Practices (cGMP). Oversee environmental monitoring, facility control, and equipment management to maintain compliance with corporate and regulatory standards . Execute validation activities and oversee environmental monitoring according to documented risk assessments and ISO classification levels.Manage day-to-day facility operations, including gowning and material transfer training for GMP personnel.Serve as the primary point of contact for integrated facility maintenance, ensuring cleanroom and supporting areas meet GMP aseptic operational standards.Manage equipment qualification, calibration, and preventive maintenance programs to maintain regulatory compliance.Collect, analyze, and trend environmental and utility sampling data, taking appropriate action to address deviations.Prepare and present facility compliance reports to internal and external stakeholders.
Essential Functions
This Facility Manager ensures that all processes and systems related to drug product release remain in a validated state, adhering to current Good Manufacturing Practices (cGMP). Oversee environmental monitoring, facility control, and equipment management to maintain compliance with corporate and regulatory standards . Execute validation activities and oversee environmental monitoring according to documented risk assessments and ISO classification levels.Manage day-to-day facility operations, including gowning and material transfer training for GMP personnel.Serve as the primary point of contact for integrated facility maintenance, ensuring cleanroom and supporting areas meet GMP aseptic operational standards.Manage equipment qualification, calibration, and preventive maintenance programs to maintain regulatory compliance.Collect, analyze, and trend environmental and utility sampling data, taking appropriate action to address deviations.Prepare and present facility compliance reports to internal and external stakeholders.
Physical Effort
Sitting and standing for long periods. Reading small print, bending and lifting up to 30 pounds and putting away lab supplies. Walking between buildings and labs. Walking to and meetings and or seminars. Walking up and down steps as necessary.
The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.
Assignment Category
Full-time regular
Job Classification
Staff.Manager - Laboratory IV
Job Family
Research
Job Sub-Family
Laboratory
Campus
Pittsburgh
Minimum Education Level Required
Bachelor's Degree
Minimum Years Of Experience Required
7
Will this position accept substitution in lieu of education or experience?
Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.
Additional Details About Required Licensure/Certification
NA
Work Schedule
Mon - Fri 8:30 - 5:00, Schedule as worked out with supervisor
Work Arrangement
Hybrid: Combination of On-Campus and Remote work as determined by the department.
Hiring Range
TBD Based Upon Qualifications
Relocation Offered
No
Visa Sponsorship Provided
No
Background Check
For position finalists, employment with the University will require successful completion of a background check
Child Protection Clearances
Not Applicable
Required Documents
Resume, Cover Letter
Optional Documents
Not Applicable
Health Sciences Core Research Facilities
This Facility Manager ensures that all processes and systems related to drug product release remain in a validated state, adhering to current Good Manufacturing Practices (cGMP). Oversee environmental monitoring, facility control, and equipment management to maintain compliance with corporate and regulatory standards . Execute validation activities and oversee environmental monitoring according to documented risk assessments and ISO classification levels.Manage day-to-day facility operations, including gowning and material transfer training for GMP personnel.Serve as the primary point of contact for integrated facility maintenance, ensuring cleanroom and supporting areas meet GMP aseptic operational standards.Manage equipment qualification, calibration, and preventive maintenance programs to maintain regulatory compliance.Collect, analyze, and trend environmental and utility sampling data, taking appropriate action to address deviations.Prepare and present facility compliance reports to internal and external stakeholders.
Essential Functions
This Facility Manager ensures that all processes and systems related to drug product release remain in a validated state, adhering to current Good Manufacturing Practices (cGMP). Oversee environmental monitoring, facility control, and equipment management to maintain compliance with corporate and regulatory standards . Execute validation activities and oversee environmental monitoring according to documented risk assessments and ISO classification levels.Manage day-to-day facility operations, including gowning and material transfer training for GMP personnel.Serve as the primary point of contact for integrated facility maintenance, ensuring cleanroom and supporting areas meet GMP aseptic operational standards.Manage equipment qualification, calibration, and preventive maintenance programs to maintain regulatory compliance.Collect, analyze, and trend environmental and utility sampling data, taking appropriate action to address deviations.Prepare and present facility compliance reports to internal and external stakeholders.
Physical Effort
Sitting and standing for long periods. Reading small print, bending and lifting up to 30 pounds and putting away lab supplies. Walking between buildings and labs. Walking to and meetings and or seminars. Walking up and down steps as necessary.
The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.
Assignment Category
Full-time regular
Job Classification
Staff.Manager - Laboratory IV
Job Family
Research
Job Sub-Family
Laboratory
Campus
Pittsburgh
Minimum Education Level Required
Bachelor's Degree
Minimum Years Of Experience Required
7
Will this position accept substitution in lieu of education or experience?
Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.
Additional Details About Required Licensure/Certification
NA
Work Schedule
Mon - Fri 8:30 - 5:00, Schedule as worked out with supervisor
Work Arrangement
Hybrid: Combination of On-Campus and Remote work as determined by the department.
Hiring Range
TBD Based Upon Qualifications
Relocation Offered
No
Visa Sponsorship Provided
No
Background Check
For position finalists, employment with the University will require successful completion of a background check
Child Protection Clearances
Not Applicable
Required Documents
Resume, Cover Letter
Optional Documents
Not Applicable
