What are the responsibilities and job description for the Director, Facilities & Engineering position at BioDuro?
Job Title: Director of Facilities & Engineering
Department: Facilities & Engineering
Reporting To: President, Drug Manufacturing US
Classification: Exempt
What We Do
Bioduro is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in Irvine, CA. Our 7 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that Bioduro is a leading partner of choice.
Why Bioduro?
Take the next step in your career and join Bioduro today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, Bioduro strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.
Job Overview/Summary
The Director, Facilities & Engineering will be involved in the management of facility remodeling and expansion projects. The role includes assistance in design of areas to be remodeled or expanded upon, contacting specific trades and general contractors for project discussions and job-walks, solicitation of project quotes, analysis of quotes to ensure project scope is met, selection of contractors, management of demolition through completion of construction, and technical point-person for problems encountered during construction. In addition, The Director, Facilities & Engineering oversees the staff and maintenance of equipment and facilities. This includes systems utilized by the maintenance department to monitor and control environmental condition and processes (i.e. BAS, Calibration, PLC, and control systems). This position will work with the operations managers and supervisors to prioritize work activities and dispatch the correct trade in a timely manner. This position will analyze and improve the processes necessary to produce products ensuring safety first. Lead problem solving efforts and continuous improvement projects to increase equipment effectiveness and process efficiencies.
Essential Functions And Responsibilities
We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, Bioduro provides employees with a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.
EOE and Accommodation
We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. Bioduro provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing humanresources@Bioduro.com. If you are selected to interview for a position, you may also request an accommodation with our team directly.
Notice to Agency and Search Firm Representatives
Bioduro is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Bioduro employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Bioduro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Department: Facilities & Engineering
Reporting To: President, Drug Manufacturing US
Classification: Exempt
What We Do
Bioduro is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in Irvine, CA. Our 7 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that Bioduro is a leading partner of choice.
Why Bioduro?
Take the next step in your career and join Bioduro today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, Bioduro strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.
Job Overview/Summary
The Director, Facilities & Engineering will be involved in the management of facility remodeling and expansion projects. The role includes assistance in design of areas to be remodeled or expanded upon, contacting specific trades and general contractors for project discussions and job-walks, solicitation of project quotes, analysis of quotes to ensure project scope is met, selection of contractors, management of demolition through completion of construction, and technical point-person for problems encountered during construction. In addition, The Director, Facilities & Engineering oversees the staff and maintenance of equipment and facilities. This includes systems utilized by the maintenance department to monitor and control environmental condition and processes (i.e. BAS, Calibration, PLC, and control systems). This position will work with the operations managers and supervisors to prioritize work activities and dispatch the correct trade in a timely manner. This position will analyze and improve the processes necessary to produce products ensuring safety first. Lead problem solving efforts and continuous improvement projects to increase equipment effectiveness and process efficiencies.
Essential Functions And Responsibilities
- Strong understanding of cleanroom HVACs, chillers and cooling towers, Siemens Apogee, low and high voltage electrical, plumbing, and city permitting requirements
- Hands-on experience managing general contractors and sub-contractor trades including but not limited to architects, HVAC mechanical, plumbing, electrical and lighting, demolition and construction, nitrogen and clean compressed air
- Sourcing of facilities equipment including researching of specialized equipment, contacting supplier and obtaining quotes, management of installation, commissioning, calibration and validation
- Responsible coordinating the activities of many different trades to ensure project stays on track and meets timeline requirements for completion
- Ability to appraise unexpected technical challenges that occur during demo and construction, formulate solutions, determine the cost of solutions, obtain approval for costs and execute to completion
- This position is responsible for compliance with all safety regulations, and Mechanical/Electrical/Fire Hazards/Elevated Workplace encountered in Manufacturing Areas
- Procure and install new manufacturing equipment to support defined targets for safety, quality, delivery and cost
- Lead continuous improvement project initiatives to ensure corporate financial goals are met
- Hire, supervise, and mentor engineers and supporting staff
- Oversee maintenance, calibration, validation and critical processing steps of manufacturing equipment
- Provide equipment technical support and troubleshooting
- Review equipment SOPs, validation protocols, NCE's and other technical documents to ensure quality and cGMP compliance
- Effectively communicate data and project status updates to clients and vendors
- Review client proposals to ensure equipment alignment for all incoming projects
- Assures that equipment is maintained in accordance with all cGMP, OSHA, governmental, and corporate standards
- Directs engineering investigations and prepares written reports when product-related equipment and system abnormalities occur
- Oversees the operation of the WFI, clean steam, compressed air, and nitrogen systems
- Monitors and prioritizes maintenance needs and assigns work as priorities dictate
- Investigates and analyzes accidents involving equipment and systems; takes appropriate corrective actions to eliminate safety hazards; and completes any required documentation in a timely manner
- Actively participates in regulatory and contract customer audits involving equipment
- Collaborates with Tech Ops and Manufacturing to support project work and new equipment FATs to ensure a smooth transition of equipment and process to operation
- Coordinates activities with the EHS team to assure that new and existing equipment applications are designed to minimize personnel safety hazards
- Leads and/or actively participates in the project management of new product and process implementations
- Collaborates with Manufacturing, Pharmaceutical Technology, and Quality Operations to control and reduce production variances
- Supports project work of PMO office as needed
- Provides regular reports to communicate departmental activities, project status, and events that impact manufacturing operations
- This job description is subject to change at any time
- BS Degree in engineering or other related field
- Minimum of 10 years experience in a manufacturing engineering environment
- Previous facility/production maintenance experience in a cGMP or regulatory environment
- Previous supervisory experience
- Pharmaceutical industry experience
- Hands-on experience working with industrial automation such as Programmable Logic Controller (PLC), Variable Frequency Drive (VFD), etc
- Strong knowledge of Manufacturing processes and equipment
- Knowledge of pharmaceutical QMS requirements for change control, investigations, and good documentation practices
- Knowledge of Blue Mountain Regulatory Asset Management or equivalent Program
- Knowledge of Building Management Systems, including State and County codes
- Experience working directly with and obtaining quotes from general contractors and specific trades including demolition, electrical, HVAC mechanical, clean compressed air and nitrogen systems, framing and drywall, flooring and ceiling contractors
- Ability to lift up to 75 lbs and manipulate 150 lbs or more
- Ability to stand for up to 8 hours per day
- Ability to be respirator certified
- Has the discipline to stay focused and complete specific tasks
- Has excellent verbal and written communication skills
- Strictly follows the company policy on client confidentiality
- Able to lead and assist in training others
We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, Bioduro provides employees with a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.
EOE and Accommodation
We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. Bioduro provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing humanresources@Bioduro.com. If you are selected to interview for a position, you may also request an accommodation with our team directly.
Notice to Agency and Search Firm Representatives
Bioduro is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Bioduro employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Bioduro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
