Instrumentation & Calibration Supervisor

Sterling Pharma Solutions; Town of Germantown (WI); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Sterling Pharma Solutions is seeking an Instrumentation & Calibration Supervisor to lead the metrology team in a fast-paced pharmaceutical production environment.

You will oversee calibration, preventive maintenance, and documentation, ensure cGMP and NIST compliance, and develop SOPs while coordinating with engineers and technicians.

Up to 5% travel required; IT skills with CMMS and MS Office are essential for success.

Competenze

• Two-year degree in a technical discipline (AS/AS) or equivalent military education.
• 3–5 years calibration/instrumentation experience preferred.
• ASQ Calibration Technician Certification (CCT) or PMEL training a plus.

Mansioni

• Oversees calibration, preventive maintenance, and repair tasks for medium-complexity instrumentation; documents results in the CMMS.
• Plans, schedules, and assigns calibration work for the instrumentation team; manages on-demand work.
• Collaborates with equipment users, engineers, and technicians to complete monthly tasks.

Conoscenze

Instrumentation

Calibration

Leadership

IT literacy

Communication

Formazione

AS/AS in technical discipline

Strumenti

CMMS

Microsoft Office

Electrical diagrams

Descrizione del lavoro

Summary of Role

The Instrumentation & Calibration Supervisor is accountable for driving results in a fast-paced environment leads the metrology team to perform instrument calibrations in a pharmaceutical production environment, maintaining calibration of metrology standards, troubleshooting instrumentation/controls, and completing and reviewing documents.

It is preferred that this candidate has working knowledge of US Food and Drug Administration CFR 21 part 820. The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• Oversees both scheduled and unscheduled calibration, preventive maintenance, and repair tasks for moderately complex process instrumentation and documents results in computerized maintenance management system database.
• Plans, schedules, and performs work for calibration/instrumentation team; including devotion of time to effectively manage on-demand assignments as they arise.
• Works closely with equipment users, engineers, and other technicians in the process of getting monthly work completed.
• Troubleshoots, inspects and repairs moderately complex test and measurement equipment and controls in support of new projects and on-demand repair requests.
• Recommend calibration standards for inspection, measurement and testing equipment.
• Prepares technical reports with recommendations for solutions to technical problems.
• Ensures compliance to NIST standards and audit readiness at all times.
• Writes Standard Operating Procedures (SOP’s), Work Instructions (WI’s), Out-Of-Tolerances (OOT’s), and Deviations.
• Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects.
• Lead role for metrology and instrumentation team, helping with work load allocation.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Provides instrumentation support, including loop checks and actuator tests.
• An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Key competencies

• Excellent understanding of circuits, components, analytical equipment and instrumentation for laboratories.
• Excellent communication and organizing skills.
• Needs to be competent with IT systems, and Microsoft Office.
• Read, understand, and update electrical diagrams.
• Duties, responsibilities, and activities may change at any time with or without notice.

Education and Experience

• Minimum of a two-year degree in a technical discipline (A.S. or A.A.S.), or equivalent military education (60-credit hours) and training.
• 3-5 years previous calibration/instrumentation experience preferred.
• Previous experience working in a GMP environment preferred.
• ASQ Calibration Technician Certification (CCT) and/or military PMEL training is a plus.

Travel Requirement

• Up to 5% travel required.

Diversity and Inclusion

Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

Why Consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.