SERAN BIOSCIENCE: Maintenance & Calibration Supervisor - Bend, OR

Employer: Seran BioScience

Job Description:
Serán BioScience provides custom formulation, process development and clinical manufacturing services for a variety of pharmaceutical clients. Our MSAT 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 and metrology department
Provides constructive and timely performance evaluations
Performs other related duties as assigned

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 and metrology 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
Performs other duties as assigned

Required Skills and Abilities
Broad knowledge of Pharmaceutical GMP standards as they are applied to FDA and international regulations
Strong verbal and written communication skills are essential with the ability to communicate at all organizational levels professionally and effectively
Excellent interpersonal and collaborative teamwork skills
Excellent organizational skills and attention to detail
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
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
Must be able to lift 15pounds at times

Contact Person: Erica Pelley
Phone: 541-237-8574
Email: [email protected]
Location: • ,
Application Method: Apply Online
Base Pay: $75,000 /YR


Posted on March 20, 2023

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