The Associate Director/Director of Technical Operations is responsible for leading the Biopharmaceutical Process Equipment Engineering & Maintenance teams with management responsibilities of direct employees, contractors and specialist vendors involved in supporting GMP manufacturing operations and maintenance. This individual will provide technical leadership, drive operational excellence, and foster a culture of safety, collaboration, and continuous improvement. A strong emphasis will be placed on quality and compliance, people management, team development, leadership, and succession planning.
Essential Duties and Responsibilities include, but are not limited to, the following:
Leading and the management of the process equipment engineering, maintenance, and calibration teams.
Providing engineering and technical support to manufacturing operations with specific focus on system and equipment continuous improvement.
Owning the introduction of new process equipment, leading the manufacturing facility modernisation program, delivering the maintenance and site calibration programs in compliance with company procedural and regulatory requirements, meeting predefined program KPIs.
Additional Responsibilities and focus areas will include.
Promoting and maintaining a team culture focused on employee development, safety, quality, innovation, and technology.
Leading and managing the Process Equipment Engineering team and the delivery of associated equipment and process improvement projects including equipment and system specification, design, commissioning, and qualification.
Leading and managing the Process Equipment Maintenance & Calibration team, ensuring delivery of GMP maintenance programs, technical support and implementation of maintenance strategies that align with business needs.
Providing technical and engineering support to manufacturing operations. Identify and implement solutions for existing equipment and manufacturing processes.
Ensuring compliance with GMP guidelines, regulatory requirements, and industry standards.
Representing the process engineering and maintenance departments and programs during audits and regulatory inspections.
Driving risk-based decision-making to assess and improve maintenance performance, implementing best practices to reduce equipment downtime and enhance reliability of equipment.
Being accountable for department budget management, headcount planning, employee development and setting the strategic direction for the organization to meet business needs.
Collaborating effectively cross-functionally and provide direction in the technical support and maintenance of manufacturing equipment.
Identifying, proposing and promoting opportunities to reduce cost while improving quality and compliance.
This role might for you if:
You have strong technical, managerial and interpersonal skills.
You have experience with equipment reliability methods, including preventive & predictive maintenance, TPM, FMEA/RCM.
You have strong communication (oral and written) and interpersonal skills to build and sustain a highly effective and performance oriented hourly team.
You have functional knowledge of Biopharmaceutical equipment maintenance.
You have knowledge of word processing, spreadsheet, and database management software (PM, MS Word, MS Excel, MS Project).
Education and Experience:
To be considered for this position you must have a Bachelor of Science/Engineering degree (chemical, electrical, mechanical, or other technical field) and 10 years of related professional experience in an engineering and/or maintenance management role.
#LI-Onsite #IREADV #REGNIRLTO #JOBSIEST
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
PSI CRO AG
Flex
TOWA. the digital growth company
