Facilities and Maintenance Technician

The Facilities and Maintenance Technician is responsible for supporting the manufacturing and process development initiatives for a cGMP pharmaceutical facility. Position will provide technical and maintenance support for Facilities/Utilities Infrastructure, Active Pharmaceutical Ingredients (API) plant processes (Reactions and Purifications) and/or Finished Drug product manufacturing (Compounding, Filling, and Packaging).

Under general supervision and according to prescribed procedures, plans and performs electrical/mechanical installations and validations, prescheduled and emergency maintenance of electrical/mechanical applications. Will be expected to assist in developing maintenance and calibration procedures for assigned area(s).

After a suitable training period, this individual must demonstrate an understanding of the equipment and processes assigned to include production equipment, process stages, control systems, and plant utility services. Will be expected to track and trend production data, identify and implement process and/or equipment improvements that will improve business measures and/or increase overall equipment reliability.

Will be expected to assist in investigating both in-process and field product complaints as well as the development and implementation of appropriate corrective actions as assigned.

Continuous running operations are expected and will require this position to be flexible to after-hours support roles as assigned.

The position Reports to the Director of Facilities and Maintenance Engineering and will have interactions with members of other departments including Quality Control, Analytical/Stability, Manufacturing, Quality Assurance, Validation, Research & Development, and outside customers.

DUTIES AND RESPONSIBILITIES:

· Electrical installation, troubleshooting, and repair from 24VDC up to 3 phase 480VAC.

· Mechanical installation, troubleshooting, and repair

· Ability to troubleshoot automation systems to include PLC's, HMI's, Vision Systems, Robotics, Servo's, etc.

· Maintain and Support Production Processes

· Keep current on all required training and SOPs

· Assist in maintaining a clean laboratory

· Adhere to safety protocols and policies

· Ensure cGMP documentation is followed

· Draft and Perform qualifications on cGMP equipment/processes as necessary

· Proactively ensure equipment is maintained to minimize disruption to production schedules

· Assists in reviewing SOPs and other relevant documentation

· Provide Mechanical, Electrical, and Control System troubleshooting and maintenance support to assigned area(s).

· Plan and Execute new or existing equipment projects as assigned

· Keep Engineering and Operations informed of process issues and plans to resolve these issues

· Provide support for Deviation's and CAPA's for assigned area(s)

QUALIFICATIONS (Education, Experience, Knowledge, and Skills):

· Relevant Work Experience or an associates degree in Industrial Maintenance, Industrial Systems, Instrumentation, Electrical Systems, Electronics, or similar field preferred

· Minimum of 3 years work experience, preferably in a cGMP pharmaceutical/medical device environment

· Have in-depth knowledge of electrical, mechanical, and automation control systems

· Ability to read and interpret electrical/mechanic schematics.

· Have in-depth knowledge of EHS

· Must be detail oriented, self-motivated, and able to multi-task in a production environment

· Must be able to create and follow written procedures relevant to assigned tasks

· Strong planning skills and project management skills

· Must have effective written and verbal English communication skills

· Work hours must be flexible to meet production timelines

· Drug screen and DEA background check required

WORKING CONDITIONS / PHYSICAL REQUIREMENTS:

Must have no physical limitations that would prevent:

• Being able to periodically lift 50 pounds or more
• Being able to climb a ladder
• Being able to wear a full-face respirator

During certain operations, the worker will be required to wear a full-face respirator and perform physically strenuous activity for extended periods of time

Must complete an annual occupational medical assessment to ensure "fit for duty"

The worker will be in an environment with electrical, chemical, explosion, fall, drop, and trip hazards

The worker will be required to handle controlled substances and work in the presence of hazardous materials with appropriate PPE, including those that are:

• Flammable/Explosive
• Carcinogenic
• Oxidizing agents
• Respiratory hazards
• Highly acidic/basic
• Under high pressure
• At high temperature
• Halogenated solvents
• Organic materials

Job Type: Full-time

Pay: From $28.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $28