With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Maintenance Planner and Scheduler works with all functions on the site to coordinate execution of calibration, validation, requalification, corrective and preventative maintenance work on site. This includes procuring all maintenance and calibration materials in support of these activities as required and kitting them for execution by both internal and external resources. Coordination of pre-approval of all qualification work is also required. Works with the Engineering and Facilities manager to coordinate license to operate facilities regulatory inspections ensuring local, state and federal compliance with applicable Codes and Regulations.
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Responsibilities- Process all work requests triaging them before converting them to work orders if required. Plans work by procuring materials, identifies and assigns resources to the work. Schedules the work by securing assets and areas with area owners, safety and quality assurance as required for safe compliant work execution.
- Plans, schedules and executes site shutdowns coordinating the facilities team and contractors, bundling work appropriately to minimize business disruption.
- Uses the CMMS exclusively in execution of all work on site.
- Generate work look ahead in accordance using the CMMS coordinating internal and external resources and areas to execute work within established due dates.
- Generate and monitor maintenance KPIs (Key Performance Indicators) on a regular basis to drive maintenance and calibration compliance and improvements.
- Supports and coordinates equipment installation and qualifications in support of equipment procurement site wide.
- Works with other facilities team members to initiate, investigate and close deviations, CAPAS and change controls in a GMP environment as required.
- Schedules and coordinates routine and emergent license to operate testing including fire protection, pressure relief device testing, back flow preventer testing and all other relevant inspections.
- Support the Manager of Engineering and Facilities with external contracts, as needed including onboarding new contractors and vendors as needed in support of work and project execution.
- Assists the Facilities team in capital project execution as required.
- Represent the Facilities group in meetings to give accounting of facility readiness and schedule work as required.
- Participate in site on call program with facilities team as required.
- Performs other related duties as assigned.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
- Communicates effectively with supervisors, colleagues, and staff.
- Ability to participate effectively as a team player in all aspects of Abzena’s business.
- Travel as needed between sites, to attend professional conferences, and train on new technologies.
Qualifications- Minimum of four (4) years of GMP or facilities management experience.
- Proficient skills with CMMS software, such as Blue Mountain Ram, SAP, Maximo or equivalent.
- Work with the QA and facilities functions to generate, investigate, and close deviations, CAPAs and Change Controls in a GMP environment. Experience from regulated industries such as the food, chemical and nuclear environments is also applicable.
- Ability to work and communicate professionally, both verbally and in written form with internal and external customers, colleagues and contractors.
- Ability to demonstrate customer service excellence.
- Proficient knowledge of Excel, Outlook, Word and PowerPoint.
- Knowledge of GMP controlled environment monitoring.
- Ability to organize and manage multiple projects simultaneously.
- Ability to perform and manage technically complex projects using independent judgment and personal initiative.
- Ability to work independently.
- Ability to complete projects and tasks within deadlines.
- Ability to recognize opportunities and adjust direction when the situation warrants.
Physical Requirements- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Frequently lift and or move objects up to 50 pounds.
- Stand/walk during entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Ability to climb, balance, stoop, kneel, crouch, or crawl.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
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FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.