Serán BioScience provides custom formulation, process development and clinical manufacturing services for a variety of pharmaceutical clients. Our Engineering, Maintenance, and Facilities Department seeks a Maintenance and Calibration Supervisor to play a crucial role in maintaining specialized equipment for the manufacturing of novel drug therapies. This role is responsible for coordinating, prioritizing, assigning, tracking, and overseeing all maintenance and calibration activities of production equipment and systems supporting manufacturing processes. Qualified candidates are those who are confident to make decisions and provides direction to ensure product quality and manufacturing efficiency. Preference will be given to candidates with pharmaceutical industry experience to best inform decisions and provide direction for the assurance of product quality and manufacturing efficiency.
Supervisory Responsibilities
- Recruits, interviews, hires, and trains new staff
- Over sees the daily work flow of the maintenance department
- Provides constructive and timely performance evaluations
- Provides mentorship, technical guidance and direction
Duties and Responsibilities
- Responsible for managing the site calibration and maintenance programs for manufacturing equipment and facility support systems using the Computerized Maintenance Management System (CMMS)
- Supervises the maintenance team, effectively communicates the team's objectives, defines success metrics, prioritizes technician's day-to-day tasks, and coordinates the activities of the contracted services for calibration, repairs, and service of equipment
- Functions as the calibration subject matter expert with an understanding of the product critical aspects, components, and labeling requirements
- Manages and directs all process equipment maintenance activities including installation, modification, calibration, repairs, and preventive maintenance in accordance with cGMP compliant maintenance processes
- Directs maintenance personnel to assure best practices ensuring effective preventative, predictive and corrective maintenance is utilized with continued operations and minimal downtime avoiding interrupted planed operations
- Ensures OOTs are effectively managed and closed promptly
- Works closely with engineering to ensure the calibration specifications are appropriate for the manufacturing processes supported
- Utilizes a Computerized Maintenance Management System (CMMS) to create E-datasheets, run reports, and ensure complete inductions are executed
- Speaks on behalf of the maintenance and calibration programs and responds effectively to inquiries prompted through internal and external compliance audits
- Responsibilities may increase in scope to align with company initiatives
- Performs other related duties as assigned
Required Skills and Abilities
- Broad knowledge of Pharmaceutical GMP standards as they are applied to FDA and international regulations
- Communicates effectively and maintains productive relationships with coworkers, clients, and other contracts outside the company
- Excellent interpersonal and collaborative teamwork skills
- Excellent organizational skills and attention to detail
- Demonstrated ability to collaborate and work in cross-functional teams
- Excellent time management skills with a proven ability to meet deadlines
- Strong analytical and problem-solving skills
- Ability to prioritize tasks and to delegate them when appropriate
- Accepts feedback from a variety of sources and constructively manages conflict
- Ability to function well in a high-paced and at times stressful environment
- Proficient with Microsoft Office Suite or related software
- Advanced knowledge of equipment maintenance and calibration systems
Education and Experience
- Bachelor's degree, preferably in Engineering, Facilities Management, or equivalent related experience
- 5+ years of lead or supervisory experience in a GMP/ISO regulated manufacturing environment preferred
- Experience in Computerized Maintenance Management System (CMMS) for scheduling all maintenance activities for both equipment and calibration preferred
Physical Requirements
- Prolonged periods of sitting at a desk and working on a computer or monitoring manufacturing equipment
- Must be able to lift 15pounds regularly, up to 30 pounds occasionally
- Adheres to consistent and predictable in-person attendance
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
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