Facilities Program Manager at Roche in Vacaville, CA
The focus of the Vacaville Operations Facility is Drug Substance bulk manufacturing. We have a passion for science, technology, innovation, professional development, and diversity and inclusion. We are also deeply respected for our unique and special culture; one that centers on the people we attract and hire. Our Pharma vision is to have a greater overall patient benefit and impact. This focus includes personalized healthcare, designing the processes with the patient in mind, and improving their quality of life. We hope you consider joining our team and being a part of one of the largest biotechnologyfacilities in the world! Job Summary We are seeking a highly motivated person, a self-starter, and an accomplished professional to lead key programs for the Maintenance and Calibration team. The facility program manager oversees key programs for management of the production facility. These programs include facility cleaning, pest control, and assigned SHE safety programs. Job
Responsibilities:
Solve a variety of routine to moderately complex issues, following cGMP regulations and Genentech standards by applying basic theory and technical principals Support the compliance of the Maintenance and Calibration department with SHE programs Oversee and provide prioritization IFM contractor work team to maintain GMP support spaces, landscaping and Non-GMP cleaning Review and approve controlled documents relating to GMP cleaning, Pest Control, facilities and FIT related work. Manage the GMP training materials for GMP cleaning, Pest Control, facilities and FIT related work. Assure that the facility areas owned Maintenance and Calibration are compliant with GMP, meet the standards of facility fit. May perform the duty of room owner. Manage the use of areas owned by Maintenance and Calibration for project lay-down and storage. Manage the maintenance program for safety equipment used by the maintenance and calibration department Manage as Roche Responsible Person for all IFM employees and sub-contractors Represent F&E on cross-functional, multi-site and multi-disciplinary teams Identify and recommend solutions to potential procedures, process and system gaps . Serve as a technical subject matter expert (SME) in support of department functions Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions. Provide oversight of the work performed by the Integrated Facility Management contractor or their subcontractors for facility repairs. Collaborate with departments and contractors to ensure that all review activities are executed safely, efficiently and effectively Generate departmental performance metrics for review by management Perform any other tasks as requested by management to support quality/facility oversight activities Organize and maintain facilities in compliance policies and procedures. Conduct and/or provide assistance with investigations including, when requested, conducting or participating in the investigation and/or review of compliance-related reports involving the facility Job Requirements Education:
B.A/B.S. degree (preferably in Life Science or Engineering) Eight year's experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience Knowledge/Skills/CompetenciesKnowledge of cGMP or equivalent regulations Ability to interpret quality and safety standards for implementation Ability to independently evaluate situations and propose potential solutions Ability to communicate clearly and professionally both in writing and verbally Flexibility in problem solving and work hours to meet business objectives Experience with training and safety programs a clear differentiator
Salary Range:
$80K -- $100K
Minimum Qualification
Program Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Solve a variety of routine to moderately complex issues, following cGMP regulations and Genentech standards by applying basic theory and technical principals Support the compliance of the Maintenance and Calibration department with SHE programs Oversee and provide prioritization IFM contractor work team to maintain GMP support spaces, landscaping and Non-GMP cleaning Review and approve controlled documents relating to GMP cleaning, Pest Control, facilities and FIT related work. Manage the GMP training materials for GMP cleaning, Pest Control, facilities and FIT related work. Assure that the facility areas owned Maintenance and Calibration are compliant with GMP, meet the standards of facility fit. May perform the duty of room owner. Manage the use of areas owned by Maintenance and Calibration for project lay-down and storage. Manage the maintenance program for safety equipment used by the maintenance and calibration department Manage as Roche Responsible Person for all IFM employees and sub-contractors Represent F&E on cross-functional, multi-site and multi-disciplinary teams Identify and recommend solutions to potential procedures, process and system gaps . Serve as a technical subject matter expert (SME) in support of department functions Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions. Provide oversight of the work performed by the Integrated Facility Management contractor or their subcontractors for facility repairs. Collaborate with departments and contractors to ensure that all review activities are executed safely, efficiently and effectively Generate departmental performance metrics for review by management Perform any other tasks as requested by management to support quality/facility oversight activities Organize and maintain facilities in compliance policies and procedures. Conduct and/or provide assistance with investigations including, when requested, conducting or participating in the investigation and/or review of compliance-related reports involving the facility Job Requirements Education:
B.A/B.S. degree (preferably in Life Science or Engineering) Eight year's experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience Knowledge/Skills/CompetenciesKnowledge of cGMP or equivalent regulations Ability to interpret quality and safety standards for implementation Ability to independently evaluate situations and propose potential solutions Ability to communicate clearly and professionally both in writing and verbally Flexibility in problem solving and work hours to meet business objectives Experience with training and safety programs a clear differentiator
Salary Range:
$80K -- $100K
Minimum Qualification
Program Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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