This position will be the cleanroom manufacturing lead in a new manufacturing facility located in Castlebar, Ireland. This facility is being brought online to expand Meissner’s manufacturing footprint into Europe to both augment our capacity as well as better serve our existing European customer base.
Single-Use Process Solutions (SUPS) are used in the manufacture of cutting edge and lifesaving medicines. They can vary greatly in terms of size and complexity, and most are unique designs. Typical production runs are between ten (10) and one-thousand (1000). Our production operations accommodate this flexibility while still ensuring that these products meet the critical quality specifications demanded by their end use.
The Production Supervisor will be responsible for coordinating the cleanroom based production operations which will be at the heart of our new facility. Staffing levels at the facility will be on the order of ten (10) for the first year of operation, twenty (20) during the second year of operation but are projected to scale to one-hundred and fifty (150) in roughly five years. Of this headcount, more than half will be cleanroom based production staff and the Production Supervisor will be responsible for coordinating this teams efforts.
Essential Duties and Responsibilities
These include the following, others may be assigned.
- Oversees a team which manufactures SUPS according to design specifications which will be communicated via engineering drawings and Standard Operating Procedures (SOPs). Actively participates in the same.
- Interfaces with computers/software which facilitates all phases of production activity including tracking of production order status, electronic batch record generation, lot control, inventory control, etc.
- Reads SOPs to properly perform necessary manufacturing operations.
- Adjusts machine settings according to SOPs.
- Initiates welding cycle of various pieces of machinery involved in production of single-use biocontainers.
- Examines and tests single-use products at various stages of production, according to SOPs, to detect nonstandard or defective assemblies.
- Maintains meticulous records of production and defects.
- Visually inspects all finished product for adherence to design specifications as well as packaging and labeling accuracy.
- Oversees and assists with packaging/shipping of all finished product.
- Observes automatic machinery and notifies operations manager and/or quality of any irregularities.
- Cleans equipment at various stages of production.
- Facilitates minor routine maintenance on production equipment.
Manages subordinate supervisors who supervise single-use systems production technicians. Responsible for the overall direction, coordination, and evaluation of these units. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
The Production Supervisor is a management position at Meissner. Excellent organization, communication and management skills are required to effectively fill this roll.
The requirements listed below are representative of the knowledge, skill, and/or ability required to successfully function in this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
- 3rd level qualification in Business, Management, Engineering or related discipline an advantage.
- Minimum 3 years experience leading a production team.
- Experience with cleanroom manufacturing is desired.
- Experience working in a regulated industry is beneficial.
- Demonstrated track record in leading, coaching, training a team and developing high potential individuals.
- Ability to analyze and resolve problems as they arise using lean /six sigma or other problem solving methodologies.
- Basic computer skills are essential with ability to quickly learn customized software applications.
- Proficiency with MS Office software including Outlook, Word, and Excel is desired.
- Experience with ERP/MRP systems
- Must have strong English Language written and verbal communication skills.
- Ability to read and interpret documents in English such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to record production results.
- A personal commitment to produce the highest quality product possible is essential.
- Ensure strict adherence to the requirements of CGMP.
Travel and Interface
As noted herein, during the first three months a reasonable amount of time, surmised to be on the order of two (2) to three (3) months will be spent at HQ. The Production Supervisor will be tasked, along with their counterparts in Camarillo, with ensuring routine contact between both production teams to ensure the transfer of best practices and production capability.