Sr. Calibration Technician

Simtra Bio Pharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement  hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

This role:

The Sr. Calibration Technician performs calibrations and maintains the calibration scheduling system to confirm facility requirements. It reports to the Calibration Manager.

The responsibilities:

* Test and calibrate measuring and test instruments for conformance to Standard Operating Procedures

* Set up test equipment, measures accuracy of instruments used to record various parameters (voltage, current, heat, flow, pressure, etc.)

* Adjust/repair instruments to meet calibration standards

* Coordinates instrument re-certification with outside standards laboratories, which includes inspections and documentation reviews on those instruments.

* Maintain calibration scheduling database and required documentation.

* Serve as a technical resource on calibration issues including investigation of out-of-tolerance events.

* Rotate on-call for off-hours and weekend support. Duties may also require overtime and weekends.

Required qualifications:

* High school diploma required (Associates Degree preferred)

* 5+ year(s) calibration experience or related field with proven problem-solving skills in pharmaceutical industry

* Basic understanding of calibration with an ability to deal with moderately complex processes and procedures

* Must be able to demonstrate judgment and initiative in problem resolution

* Must be able to work unsupervised

* Good communication skills and detail oriented

* Working knowledge of 21

CFR and cGMP regulations

* Work experience in a clean room environment a plus

* Duties may require overtime work, including nights and weekends

Physical / safety requirements:

* Must be able to lift, push/pull, and carry up to 55 pounds

* Must wear personal protective equipment (PPE), including respirator

* May be required to work with pressurized equipment, hot surfaces

* May be required to work in confined spaces

* Position requires standing for long hours

* Ability to qualify for Grade B gowning

In return, you'll be eligible for[1]:

* Day One Benefits

* Medical & Dental Coverage

* Flexible Spending Accounts

* Life and AD&D Insurance

* Supplemental Life Insurance

* Spouse Life Insurance

* Child Life Insurance

* 401(k) Retirement Savings Plan with Company Match

* Time Off Program

* Paid Holidays

* Paid Time Off

* Paid Parental Leave and more

* Adoption Reimbursement Program

* Education Assistance Program

* Employee Assistance Program

* Community and Volunteer Service Program

* Employee Ownership Plan

* Additional Benefits

* Short and Long-Term…