CMMS Planner / Scheduler responsible for planning, coordinating, administering, and optimising maintenance activities through SAP CMMS to ensure the safe, compliant, and efficient operation of site assets.
Responsibilities
Plan, schedule, and coordinate preventive, predictive, and corrective maintenance activities
Develop detailed maintenance work plans
Manage maintenance schedules and work orders within SAP CMMS
Maintain SAP master data
Collaborate with Maintenance, Engineering, Operations, Stores, Procurement, Contractors, and external vendors
Requirements
HNC/HND or equivalent qualification/experience in Engineering, Maintenance, Manufacturing, Business Administration, or a related discipline
Lead complex biologics technology transfers to accelerate life‑changing therapies at a Dublin manufacturing facility.
Responsibilities
Lead multiple technology transfers of bulk drug substance processes to achieve process validation readiness and on‑time PPQ completion
Define and execute validation strategies, author validation documentation, and guide PPQ activities to meet regulatory and business milestones
Own delivery of process documentation, gap assessments, technical protocols and reports, and strategy documents that enable robust commercial execution
Identify and implement process improvements, including AI‑enabled tools, to reduce transfer lead times, improve yield, and shorten cycle times
Determine requirements for supporting lab studies; partner with Process Development/MSAT on design and execution to de‑risk scale‑up and transfer decisions
Requirements
Nice to have: PPQ and process validation strategies
Assist in assuring that all of Terrestrial Bio’s critical Equipment and Analytical Instruments are operating within expected parameters in support of the manufacture, testing, and storage of Terrestrial's combination products.
Locations (2)
Woburn, Massachusetts, United States
Allston, Massachusetts, United States
Compensation
The anticipated base salary range for this position is $70,000 - $93,000.
Responsibilities
Assist in oversight of calibration schedules and procedures for equipment and instrumentation used in the manufacture, testing, and storage of cGMP products.
Ensure that all work aligns with Good Manufacturing Processes (cGMP), Good Documentation Practices (GDP) and 21 CFR Part 11, Electronic Record Standards as applicable.
Identify and evaluate root cause investigations for equipment and analytical instruments deviations and implement Corrective and Preventative Actions (CAPA) as needed.
Author, review, approve, and revise Standard Operating Procedures (SOPs) and equipment related protocols such as Installation Qualifications, Operation Qualifications, and Performance Qualifications (IQOQPQ).
Support lifecycle management, qualification, and compliance of temperature-controlled equipment and analytical laboratory instrumentation at the Swiftwater, PA site.
Responsibilities
Execute and support temperature mapping and qualification of Controlled Temperature Units (CTUs)
Perform CTU temperature mapping studies using Ellab data loggers
Support development, review, and execution of CTU mapping and qualification protocols
Evaluate mapping data against approved specifications
Support IQ/OQ/PQ activities associated with CTUs
Requirements
Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline
Nice to have: 3+ years of experience supporting CTU qualification
Nice to have: Hands-on CTU mapping and qualification experience
Nice to have: Experience performing temperature mapping studies using Ellab data loggers
Nice to have: Experience with logger configuration, placement, deployment, data retrieval, analysis, and troubleshooting
Support lifecycle management, qualification, and compliance of temperature-controlled equipment and analytical laboratory instrumentation at the Swiftwater, PA site.
Responsibilities
Support temperature mapping and qualification of Controlled Temperature Units (CTUs)
Perform CTU temperature mapping studies using Ellab data loggers or comparable systems
Support development and execution of CTU mapping and qualification protocols
Evaluate mapping data against specifications and support investigation of temperature excursions
Support IQ/OQ/PQ activities for CTUs and other equipment
Requirements
Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline
Nice to have: 3 years of experience supporting CTU qualification
Nice to have: Experience with HPLC, GC, spectroscopy, dissolution, TOC, conductivity, particle counters, balances, microbiological instrumentation
Nice to have: Experience with computerized laboratory systems and eQMS
Supports manufacturing activities by cleaning, disinfecting, and sanitizing aseptic cleanroom environments between production shifts and completing corresponding documentation within an outsourcing facility.
Responsibilities
Disinfect aseptic areas per SOPs
Complete routine and enhanced cleaning of aseptic cleanrooms and supporting areas
Aseptically don sterile garbing and demonstrate aseptic technique
Accurately prepare, label, and use cleaning materials and solutions
Accurately sort and dispose of pharmaceutical waste materials
Requirements
High school diploma or GED required
Nice to have: High integrity and the ability to work in changing environment
Nice to have: Good interpersonal and communication skills
Nice to have: Willing to work extended hours, complete repetitive tasks and stand for prolonged periods of time
Nice to have: Ability to work on your own or within a team environment
Responsible for sterile drug preparation and aseptic filling operations in a regulated pharmaceutical manufacturing environment.
Compensation
$2.00/hour shift differential for 2nd shift, $3.00/hour shift differential for 3rd shift
Responsibilities
Follow SOPs, product batch record instructions, and corresponding quality documentation
Set up and operate filling, decontamination, and sterilization equipment
Prepare and maintain accurate documentation following cGMP and GDP principles
Ensure proper accountability and traceability of components, ingredients, and finished products
Report and make recommendations regarding equipment, facilities, supplies, required repairs, process concerns, safety concerns, and areas for improvement in quality, yield, and efficiency
Requirements
High school diploma or GED
Nice to have: Understanding of scientific formulations
Responsible for executing advanced clinical labeling and packaging operations with minimal supervision, ensuring compliance with cGMP, SOPs, and regulatory requirements.
Compensation
Competitive Pay, plus - 10% Shift Differential for 2nd Shift, 15% Shift Differential for 3rd Shift
Responsibilities
Set up, operate, and monitor labeling and packaging equipment while ensuring adherence to batch records, work instructions, and quality standards
Perform and document line clearances, in-process checks, reconciliation activities, and batch record review to ensure compliance and inspection readiness
Identify and troubleshoot process or equipment issues, escalating as needed, and contributing to continuous improvement initiatives and Right First Time execution
Requirements
High school diploma or equivalent
Nice to have: cleanroom environment experience
Nice to have: labeling and/or packaging operations in a pharmaceutical or clinical supply setting
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