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About the Role

Direct and oversee production process operations, ensuring safety and compliance with GMP and Standard Operating Procedures (SOPs). Improve operational efficiency by analyzing and correcting production problems and coordinating with other departments for scheduling and batch record completion.

Responsibilities

Provide supervision and direction to staff, coordinating workflow, distributing work, and resolving problems.
Monitor subordinates' attendance, review leave requests, authorize overtime, and approve timecards.
Manage employee performance through clear responsibilities, feedback, and corrective action.
Evaluate and appraise employee performance with proper documentation.
Investigate and address employee complaints, following up with management and HR.
Ensure staff maintain up-to-date technical knowledge and developments impacting their roles.
Create a learning environment by coaching employees and providing feedback.
Assist in interviewing and hiring subordinate staff.
Understand and apply HR policies and practices in employee management.
Conduct training needs assessments and maintain training/skill matrices.
Investigate process deviations, identify root causes, and provide effective CAPAs.
Lead daily production meetings, review performance, and coordinate with other groups for resources.
Execute the production schedule, anticipating and mitigating operational issues through planning and communication.
Communicate corporate, department, and shift-to-shift information.
Identify weekly labor requirements and develop schedules in conjunction with the Manager.
Coordinate activities with other shifts based on production requirements and priorities.
Develop and maintain departmental cross-functional training matrices.
Actively manage overtime to minimize hours required to meet the schedule.
Participate in Safety/GMP Audit Programs.
Halt processes and notify QA and Manager of any concerns about product safety or quality.
Participate in investigations and prepare PR/Audit documentation.
Ensure stakeholders are trained on processes and changes.
Identify and implement improvements in GMP, compliance, waste reduction, and process streamlining.
Evaluate SOP effectiveness, identify necessary changes, and ensure change control documentation is implemented.
Review, edit, and approve Operations documents.
Monitor production area conditions for organization and hazard-free status.
Verify employee adherence to GMPs, safety regulations, and workplace SOPs.
Address observed violations and notify management.
Hold regular safety meetings.

Requirements

B.S. degree strongly preferred with 2 years related experience preferably in a pharmaceutical or regulated environment; or Associate’s degree with 5 years related experience preferably in a pharmaceutical or regulated environment; and 2 years previous supervisory experience preferred.
Previous food/drug/chemical industry experience.
Ability to lead and maintain adequate level of performance of individuals engaged in job tasks that are highly structured, routine, and repetitive.
Ability to resolve problems and issues to ensure efficient flow of manufacturing operations and work completion.
Basic math skills and ability to understand the metric system required.
Must be able to lift 50 pounds to lift and maneuver bulk containers of ingredients.
Must have physical mobility and dexterity to frequently stand, bend, push, twist, kneel, climb, stoop, and reach overhead and be able to stand for extended periods of time while performing duties.
Considerable mental/visual concentration, coordinating manual dexterity.
Must be able to operate power equipment; routinely drives/operates lifts.
Must be able to work safely with materials and equipment; works with chemicals, tools, and equipment.
May work in an environment with variable but moderately high noise levels (hearing protection recommended).
Must wear safety glasses, safety shoes, gloves, and other protective items as required.
Must wear appropriate garments and coverings per cGMP (uniforms, hair/beard nets, etc.).
Must be available for flexible schedule and/or overtime.
Days and hours of work are subject to change due to production schedules.
Works with chemicals, tools and other equipment.

Skills

Supervision
Production Process Management
GMP Compliance
SOP Compliance
Problem Solving
Process Improvement
Team Leadership
Performance Management
Root Cause Analysis
CAPA Implementation
Production Scheduling
Resource Management
Training Matrix Development
Overtime Management
Safety Compliance
Audit Participation
Process Deviation Investigation
Change Control Management
Basic Math Skills
Metric System Understanding

Location

Rochester, NY

Work Type

Full-time
Onsite

Experience Level

2 years related experience
5 years related experience
2 years previous supervisory experience preferred

Education Level

B.S. degree
Associate's degree

Salary/Compensations

82,000.00 - 92,000.00 USD

Benefits

100% employer-paid medical premiums
401(k) contributions: 6% match plus an additional 4% company-funded contribution
HSA contributions with wellness incentives
Annual performance bonuses
Merit increase eligibility

About the Company

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible.
As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees.
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation.
We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
Join us and make a difference!

Equal Opportunity

Unither is an Equal Opportunity Employer.
We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.