About the Role
This position is charged with the overall responsibility for the installation, calibration and maintenance of facility and processing instrumentation and controls. This position will ensure that the facility and processing control systems of ANI Pharmaceuticals, Baudette Operations are calibrated and maintained in a fashion that provides for the manufacture of pharmaceutical product in a GMP environment. This includes the calibration and maintenance of environmental, process and laboratory instrumentation and controls.
Responsibilities include but are not limited to:
- Supervision of the Metrology, and Calibrations functions. This includes coordinating work activity, project assignments, using the database and tracking for on time completion.
- Evaluation of instrumentation and controls, utilizing a central calibration control system for the allocation of resources necessary to keep them in a state of operation consistent with current cGMP’s.
- Writing and review of GMP documentation.
- Facility Control Systems and Process Engineering project evaluation and planning.
- Administration and purchase of part and supply inventories within the Metrology and Calibration operating budget.
- Provide for administration of service agreements and other support for outside contractors as required.
- Performs other duties as assigned or requested.
- Bachelor’s Degree in a related area.
- 1 – 3 years in the installation, maintenance and calibration of instrumentation and controls within an ISO 9000 certified and/or cGMP regulated facility.
- Must have some supervisory experience
Minimum Field of Expertise
- Ability to assign and monitor the work of other team members.
- Ability to manage multiple projects within a fast paced environment.
- Ability to train and influence others to promote automation changes.
- Attention to detail
- Excellent technical writing and communication skills
- Strong Interpersonal skills.
- Strong organizational skills to prioritize work activities within project and operational budgets and in a manner consistent with cGMP’s.
- Strong understanding of the Support Services Department activities and processes.
- Ability to lift up to 20 lbs
Preferred Field-of-Expertise Ability to train and provide guidance to personnel within assigned area.
- Demonstrated leadership skills
- Knowledge of control and instrumentation systems.
- Previous work in a regulated environment
- Problem solving skills
- Project management with the ability to plan, organize, develop, implement and interpret programs, budgets, plans, and objectives.
- Strong experience coordinating activities of technical teams.
- Life Insurance
- Short-Term Disability and Long-Term Disability
- Employee Assistance Program
- 401(k) Savings Plan
- Company Paid Holidays (10)
- Paid Time-Off
- Other Paid Leave
- Employee Stock Purchase Plan (ESPP)
- Opportunity to advance in company positions