Metrology Specialist

PCI Pharma Services; Philadelphia (Philadelphia County); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Philadelphia, PA, seeks a Metrology Specialist to oversee calibration programs site-wide, ensure compliance with GxP, and support measurement systems. The role involves data collection, trend analysis, and coordinating calibration activities with contractors, with no supervisory duties.

The ideal candidate has a Bachelor's degree in a related field and 5–10 years of calibration experience, strong mathematical and computer skills, and knowledge of cGMP/FDA requirements.

Qualifications

• Bachelor's degree in a related field is required.
• 5–10 years of calibration/related experience or training.
• College-level mathematical skills required.
• Advanced computer skills required for data analysis and instrumentation.
• Knowledge of GxP, cGMP, and regulatory standards is preferred.

Responsibilities

• Lead calibration activities site-wide to meet regulatory requirements.
• Perform complex calibrations in temperature, pressure, conductivity, humidity, and related areas.
• Collect, compile, and trend calibration data for performance evaluation.
• Investigate non-conformities related to metrology/calibration processes.
• Write and improve calibration procedures and methods.
• Coordinate calibration contractors for on- and off-site work.
• Ensure adherence to cGMP and GxP policies and standards.
• Support studies and testing of measurement equipment.

Skills

College level mathematical skills

Advanced computer skills

Regulatory knowledge: GxP, FDA

Independent work capability

Education

Bachelor's degree in a related field

5–10 years related experience

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: 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:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

A Metrology Specialist is expected to lead the business beyond of the normal scope of task-based project calibration. Knowledge, experience, personal drive, and creativity will motivate this individual to present new ideas to senior management that will affect the direction of the organization over the next years. These ideas could be focused around:

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

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 Depth Perception
• Ability to focus No Special Vision Requirements

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• 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:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

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.