Manufacturing Supervisor
BMA Group — Jayuya, PR
Job Description
The Manufacturing Supervisor, supervises processes and personnel in commercial production environment while maintaining cGMP, environmental health and safety guidelines and any other related regulations that apply. In addition to being fully accountable and involved in all production processes, he/she may problem solve in other functional areas. The incumbent acts as a delegate to the Manager and may conduct departmental activities in their absence. He/She fully understands the regulations and may make recommendations according to their interpretations. The Manufacturing Supervisor is responsible for the successful transfer of new processes/methodologies into the manufacturing area.
Essential Duties & Responsibilities
Supervise the day to day production, scheduling, staffing, material management, compliance, training, and auditing activities for area of responsibility.
Develop and manage performance of direct reports.
Support and ensure execution of all manufacturing processes with strict compliance to cGMPs and EHS regulations.
Perform or support technical reviews, investigation and process improvement projects.
Provide input into integration and validation of new equipment and process.
Resolve technical, material, and cGMP issues.
Review, approve, and manage documentation for batch and system records for production.
Interface with other departments to help resolve issues related to equipment, process and compliance including facility support departments and external vendors.
Lead/participate in technical reviews, investigation and process improvement projects in order to meet objectives
Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, assist with training and auditing as appropriate.
Owner for implementation of new equipment, system and/or procedures.
Participate in Internal or external audits as SME for department.
May perform other duties as assigned.
Qualifications
The Manufacturing Supervisor should be able to identify errors or faults in process and recommend or implement solutions.
Basic supervisory and leadership skills.
Able to manage multiple priorities in manufacturing plant setting
May have knowledge of Cell Culture, Purification, and Buffer/Media manufacturing operations.
Understands Manufacturing Production Process for all functional areas. Expertise grows in depth and breadth as individual moves up the career ladder.
Knowledge of Utility Systems and how they impact the Manufacturing Departments.
Understands the flow and design/interdependency of manufacturing support departments.
Knowledge of manufacturing equipment operation, including set up and changeover, as well as commissioning, validation, and troubleshooting.
Basic scientific understanding of biology (cell culture, microbiology) and chemistry/ biochemistry as it applies to the manufacturing process.
May have more specific skill sets in areas depending on need/ opportunity: Aseptic technique, column packing, inoculum operations, chromatography operations, etc.
Knowledge of clean room management.
Strong professional writing skills and ability to prepare and write technical reports
Strong verbal and written communication skills across multiple functional areas.
Computer skills, including PowerPoint, Word, Excel, Access.
Knowledge of basic chemical and biological safety procedures.
Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
Must be able to read, write, and converse in English.
Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.
Must have the ability to navigate electronic mail systems and intranet for communication purposes.
Advanced word processing skills.
Advanced spreadsheet skills.
Advanced typing skills.
Good interpersonal skills and be able to work effectively and efficiently in a team environment.
Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
Must have passion to innovate and drive for solutions.
Must display personal accountability for results and integrity.
Must display eagerness to learn and continuously improve.
Must have uncompromising dedication to quality.
Must have relentless focus on rapid and disciplined action.
Must have respect for individuals and the diverse contributions of all.
Education and/or Experience
Bachelors Degree plus 1-3 years of manufacturing experience, or AA Degree with 3-6 years of manufacturing experience, or HS Diploma with 5-8 years of manufacturing experience. Minimum of 0-2 years of leadership experience. Scientific or engineering degree preferred.
Job Type: Full-time
Benefits:
None
Schedule:
Day shift
