Setup Mechanic 1st, 2nd and 3rd Shift

Job Description

Job Overview:

The Setup Technician is responsible for maintenance and operational support of production scale industrial equipment needed for the manufacture of parenteral pharmaceuticals. Additional duties will include parts and tool management, plant, and manufacturing equipment support.

Responsibilities:

Comply/adhere with cGMP regulations, policies, SOPs, and batch records.

Installs, maintains, operates repairs and troubleshoots equipment.

Coordinates contracted maintenance activities with vendors.

To identify, investigate, participate in and when necessary to take ownership of compliance issues and deviations when discovered and to support the identification and implementation of corrective and preventive actions (CAPAs).

To work cooperatively with the Quality Assurance and other internal departments to ensure appropriate coordination of manufacturing activities.

To ensure that all SOPs, batch records, manufacturing logbooks and other related documentation are completed according to GMP and Good Documentation Practices.

To participate in relevant meetings and additionally to report on/contribute to job/safety related matters as appropriate.

Observes safety and security procedures; responsible for meeting department safety objectives and to adhere to on-going safe operating procedures consistent with the job requirements.

To complete assigned trainings in a timely fashion to ensure that both personal and department training status remains current.

Perform other duties as assigned.

Qualifications:

High School Diploma, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

3 years or more years related work experience (GMP / Bio-Pharma maintenance/ engineering); clean room experience or experience in a similarly regulated industry.

Proficiency with math, the metric system, weight and volume measures.

Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.

Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.

Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.

Must be able to comprehend and follow all applicable SOPs.

Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.

Good understanding of cGMPs, industry, and regulatory standards and guidelines.

Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.

Demonstrate the ability to portray the appropriate level of integrity and professionalism.

Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.

Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.

Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.

Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.

Results-oriented and efficient.

Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.

Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).

Demonstrate the ability to work well in a cross-functional team environment.

Must communicate fluently in English and have legible handwriting.

Physical Demands:

Ability to work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical.

Must be willing and able to have potential limited exposure to hazardous chemicals.

Ability to travel between and within facilities to visit staff, operations, and projects, as needed.

Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).

Ability to lift up to 40 pounds on occasion.

Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).