Metrology Specialist

PCI TRGR Penn Pharmaceutical Services Ltd; Philadelphia (Philadelphia County); Hybrid; USD 70,000 - 95,000; Full time

Job summary

PCI Pharma Services in Philadelphia seeks a Metrology Specialist to oversee, calibrate, and maintain measuring equipment site-wide. You will ensure compliance with GxP, NIST, and ISO standards, and support calibration-related projects.

The role requires performing complex calibrations, data collection and trend analysis, and resolving non-conformities with minimal supervision.

Qualifications

• Bachelor's Degree in a related field; 5–10 years related experience considered.
• Advanced mathematical and statistical abilities.
• Able to interpret complex technical instructions and data.

Responsibilities

• Perform complex calibrations in temperature, pressure, conductivity, humidity, flow, mass, etc.
• Write/Improve calibration procedures and methods.
• Collect, measure, and trend calibration data; ensure GMP/GxP compliance.
• Investigate non-conformities and support troubleshooting.
• Coordinate calibrations and support calibration-related projects.

Skills

Math skills

Advanced computer skills

Analytical thinking

Problem solving

Communication

Education

Bachelor's Degree in a related field

Tools

Minitab

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Position Title, Location & Shift

Metrology Specialist

Location: 3001 Red Lion Road, Philadelphia, PA 19114

Shift: 1st Shift

The Metrology Specialist is responsible for the oversight, calibration, and maintenance of measuring equipment site-wide and ensure compliance with GxPs as well as global/site requirements for calibration compliance under minimal supervision. The Metrology Specialist will improve and support the safe and effective completion of calibrations and support troubleshooting, problem solving, data analysis, and project implementation for measurement systems. There are no supervisory responsibilities for the role.

Essential Duties and Responsibilities

1. Perform complex calibrations in the areas of temperature, pressure, conductivity, humidity, flow, mass, etc.
2. Accurately perform complex mathematical formulas relating to calibrations.
3. Ensure all calibrations are performed per regulatory, GxP, and global/site requirements.
4. Collect, compile, measure, record, and trend data gathered from calibrations.
5. Evaluate measuring equipment performance and effectiveness of tasks and frequencies.
6. Perform failure investigations (non-conformities) related to Metrology/Calibration processes.
7. Write/Improve calibration procedures and methods according to technical requirements.
8. Support and/or execute studies and testing involving measuring equipment.
9. Provide coaching and support to process owners for measuring equipment and instruments (calibration specifications, problem solving, instrument selection, failure investigation).
10. Drive improvements in calibration methods, standards, and specifications to meet customer/site needs.
11. Coordinate calibration contractors for performance of calibrations on and off site.
12. Maintain critical metrology standards, equipment, and tools.
13. This position may require overtime and/or weekend work.
14. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
15. Knowledge of NIST and ISO related standards.
16. Attendance to work is an essential function of this position.
17. Performs other duties as assigned by Manager/Supervisor.

Special Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions - Stationary Position: From 1/2 to 3/4 of the day. Move, Traverse: From 1/2 to 3/4 of the day. Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day. Install, place, adjust, apply, measure, use, or signal: From 1/4 to 1/2 of the day. Ascend/Descend or Work Atop: Up to 1/4 of the day. Position self (to) or Move (about or to): From 1/4 to 1/2 of the day. Communicate or exchange information: 3/4 of the day and up. Detect, distinguish, or determine: 3/4 of the day and up. On an average day, the individual can expect to move and/or transport up to 50 pounds less than 1/4 of the day. This position may have the following special vision requirements. Close Vision Distance Vision Color Vision Peripheral Vision Ability to focus No Special Vision Requirements.

Work Environment

Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 1/2 to 3/4 of the day. Work is primarily performed at a desk and/or in an office environment for 1/4 to 1/2 of the day. Work near moving mechanical parts for 1/2 to 3/4 of the day. Extreme cold (non-weather) for up to 1/4 of the day. Risk of electrical shock for up to 1/4 of the day. Vibration for up to 1/4 of the day. The noise level in the work environment is typically, moderate.

Qualifications

Required:

• Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.
• College Level Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• High Standard of Report Writing
• Ability to effectively present information to various people as the job requires.
• Ability to follow instructions and respond to management direction.
• Ability to identify and resolve problems in a timely manner.
• Ability to work independently and/or as part of a team.
• Knowledge and experience in cGMPs, FDA and other international regulatory agency regulations.

Preferred:

• Knowledge of statistics, Six Sigma, DOE, and other improvement techniques.
• Ability to support and lead cross-functional teams in Gauge Repeatability & Reproducibility.
• Application of Failure Mode Effect Analysis.
• Experience utilizing Minitab or similar programs for statistical analysis.

#LI-KH1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.