Equipment Specialist, Lyophilization
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
- The Equipment Specialist is responsible for maintenance and operational support of production scale industrial refrigeration equipment needed for the manufacture of parenteral pharmaceuticals at the Rockville facility.
- Additional duties will include parts and tool management, plant and manufacturing equipment support, parts design, as well as management of moderately sized capital projects.
- Comply/adhere with cGMP regulations, policies, SOPs and batch records
- Assist the Validation department with the operation and execution of engineering projects related to all phases of the lyophilization process.
- Under the supervision of the Sr. Manager Facilities and Lyophilization Supervisor, installs, maintains, operates repairs and troubleshoots low-temperature refrigeration systems.
- Installs, maintains, overhauls, and operates refrigeration equipment including compressors, pumps, evaporators, expansion valves, solenoid valves, all controls, condensers, and other related components.
- Focus to process improvement throughout the manufacturing and packaging areas.
- Coordinate and perform preventive/reactive maintenance on lyophilization equipment.
- Maintains detailed maintenance and spare parts records.
- Coordinates contracted maintenance activities with vendors.
- Assists in qualification of equipment/facilities as needed.
- Compiles, analyzes, draws conclusions, and provides written documentation related to the maintenance and lifecycle of production systems.
- Administers project management controls and reports status to senior management.
- Involved in the oversight and coordination of activities that include design, specification creation, procurement, construction management, repair of production and facilities equipment.
- Utilizing the Building Automation Systems (BAS) monitors lyophilization systems, manufacturing and laboratory environments, refrigeration units, incubators, etc. Operates BAS terminals to monitor, trouble shoot, and maintain applicable system performance consistent with required unit and/or area conditions, following all change control procedures.
- Ability to read P&ID drawings. Control schematics; ability to analyze refrigeration problems and take corrective action; ability to upload and download programs and utilize computer-based Building Automation Systems for trouble shooting and monitoring system performance.
- Assignments are broad in nature, requiring originality and ingenuity, and rely on collaboration, limited experience, and judgment to plan and accomplish goals
- Assists in programming, maintenance and troubleshooting of programmable logic controllers and process/environmental monitoring systems.
- Establish procedures with some supervision.
- Performs equipment calibrations.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
EDUCATION, EXPERIENCE & SKILLS
- At least three (3) years of the last seven (7) years full-time experience as a journey-person HVAC/Refrigeration mechanic maintaining and troubleshooting industrial refrigeration and air conditioning equipment and associated controls. This includes but is not limited to servicing: at least 50-Ton HVAC/Refrigeration systems and/or servicing low temperature refrigeration systems, ability to interface with automated building/refrigeration.
- Minimum of 5 years of experience working with low temperature refrigeration equipment in industrial/pharmaceutical engineering/maintenance setting.
- Robust troubleshooting skills regarding refrigeration, electrical and mechanical concepts.
- Knowledge of lyophilization thermodynamic cycles is desired.
- Must possess the ability to identify and resolve problems in a timely manner while gathering and analyzing information skillfully.
- PLC and process control troubleshooting skills required.
- Proven track record of applying broad knowledge of engineering principles, practices and procedures to the completion of moderately difficult assignments.
- Experience with clean steam systems as well as WFI systems.
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
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Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.