Position SummaryThe Sterile Operations Supervisor reports to the Associate Director, Sterile Operations and provides hands-on, front-line leadership for the daily execution of sterile drug product manufacturing. The role directly supervises the operator team, coordinates shift activities, and ensures safe, compliant, and reliable execution across the complete process train. The Supervisor supports assigned quality system documents and events, implements approved requirements on the manufacturing floor, and escalates matters requiring department-level or Quality approval.
*This is a 1st Shift role; Monday to Friday from 7:00am to 3:30pm.* Essential Duties and Responsibilities- Supervise daily sterile manufacturing execution across formulation, component preparation, isolator filling, inspection, and device assembly.
- Convert the approved production schedule into daily work assignments and coordinate operator coverage, equipment readiness, materials, and training needs for the four-operator team.
- Provide direct people supervision, coaching, attendance oversight, performance feedback, and development support in accordance with company policy and in partnership with the Associate Director and Human Resources.
- Verify that operators are appropriately trained and qualified before independent task execution and promptly address or escalate qualification gaps.
- Lead daily tier meetings, shift handoffs, floor communications, and first-line escalation; coordinate routine execution with Quality, Engineering, Validation, MS&T/Technical Operations, Supply Chain, EHS, and Maintenance.
- Serve as the front-line operational point of contact for assigned manufacturing equipment and processes; escalate decisions requiring business-owner, technical-owner, or department-level authority.
- Support equipment commissioning, qualification, process validation, aseptic process simulations/media fills, technology transfer, and production-readiness activities.
- Review batch records, logbooks, forms, and electronic records for completeness, accuracy, contemporaneous documentation, and readiness for formal review.
- Maintain area and personnel inspection readiness and support Sterile Operations during internal audits and health authority inspections.
- Monitor daily safety, quality, delivery, training, and performance indicators; communicate emerging risks and recommend corrective actions to the Associate Director.
Quality System and Compliance Responsibilities- Draft, revise, route, implement, and maintain assigned SOPs, work instructions, forms, batch records, protocols, reports, and other QMS documents under the applicable review and approval process.
- Initiate or support assigned deviations, investigations, CAPAs, change controls, risk assessments, effectiveness checks, and action items within authorized responsibility.
- Gather facts, establish clear event timelines, participate in root-cause analysis, recommend practical corrective and preventive actions, and track assigned commitments to completion.
- Ensure floor activities comply with approved procedures, cGMP, data integrity expectations, aseptic processing controls, contamination control requirements, and applicable company policies.
- Implement approved quality-system actions and procedural changes on the manufacturing floor and verify operator understanding and adherence.
- Partner with Quality and promptly escalate disposition-impacting events, environmental or personnel monitoring excursions, process anomalies, documentation concerns, and visual inspection defect trends.
- Maintain clear supervisory boundaries by escalating final product-disposition decisions, significant compliance risks, and changes requiring department-level or Quality approval.
Minimum QualificationsEducation Bachelor's degree in engineering, microbiology, biochemistry, pharmaceutical sciences, biotechnology, or a related scientific or technical field preferred. An associate degree, technical credential, or equivalent combination of education and directly relevant experience may be considered.
Experience 5-7+ years of pharmaceutical or biotechnology manufacturing experience, preferably including sterile or aseptic operations, with 2+ years of demonstrated lead, supervisory, or people-leadership experience.
Required Knowledge, Skills, and Abilities - Working knowledge of sterile drug product manufacturing, aseptic processing, contamination control, cleanroom behavior, EU GMP Annex 1, U.S. FDA 21 CFR Parts 210 and 211, and applicable visual inspection requirements, including USP and .
- Demonstrated ability to supervise personnel and coordinate production in a regulated pharmaceutical or biotechnology environment.
- Sound technical writing and investigation-support skills, including the ability to draft QMS content and provide clear, factual event documentation.
- Ability to interpret batch records, process data, equipment alarms, qualification documents, and production metrics and to escalate abnormal conditions appropriately.
- Strong communication, prioritization, conflict-resolution, coaching, problem-solving, and cross-functional coordination skills.
- Working knowledge of electronic document, training, manufacturing, or quality systems used in regulated operations.
- Ability to make timely floor-level decisions within approved procedures and clearly recognize matters requiring escalation to the Associate Director, Quality, or a designated system owner.
Physical and Work Environment Requirements - Ability to work in classified cleanroom environments and wear required gowning and personal protective equipment for extended periods.
- Ability to stand, walk, reach, bend, and perform repetitive tasks for extended periods.
- Ability to lift and move materials within company-defined safe-lifting limits, with assistance or mechanical aids when required.
- Ability to pass the company-approved visual inspection qualification, including applicable near-vision requirements, when visual inspection duties are assigned.
- Ability to work around cleaning agents, sanitizers, disinfectants, and VHP-controlled equipment in accordance with approved safety procedures.
- Ability to work the assigned schedule and modified schedules during qualifications, media fills, campaigns, shutdowns, or business-critical events.
The duties and responsibilities described above are not intended to be an exhaustive list. Additional duties may be assigned based on business needs. Reasonable accommodation may be made to enable qualified individuals to perform the essential functions of the position.
Pay Range: $84,000 - $126,000 per year
