HVAC Engineer II

• New facility build (King of Prussia area) in Q2 2021; in this role you would lead QC (team of 30 people at this site)
• Organization boasts 40+ year history, privately held, very profitable, cutting‑edge technologies that continue to impress and acquire customers across the biggest industries; pharmaceutical, life sciences, energy, food/bev, petrochemical, power, pulp/paper, semiconductor, etc.
• Operations in 40+ countries; dynamic, growing organization is complex; with 25+ holding companies globally and 5 R&D centers.

Quality Control Supervisor (Greenfield Operations)

King of Prussia, PA

Our executive search firm is looking for a QC Supervisor to help lead ground‑breaking operational efforts for a new facility (literally – greenfield operations!). This organization boasts 40+ year history, privately held (cash‑heavy), and cutting‑edge technologies that continue to impress and acquire customers across the biggest industries; pharmaceutical, life sciences, energy, food/bev, petrochemical, power, pulp/paper, semiconductor, etc. They manufacturer/operate in more than 40 countries;

yet do not have pharmaceutical clean‑rooms in the USA; hence the birth of this project). This dynamic, growing organization is complex; with 25+ holding companies globally and 5 R&D centers.

Main area of focus:

We are looking for the key leader who will oversee quality control for a new API manufacturing facility; ensuring top notch compliance with all regulations and supporting facility audits.

Proficiency in laboratory techniques. Working knowledge of cGMP Part II Guidelines, FDA Regulations, and ISO 9001:2008 and ISO 19011:2011 is desirable. Working experience with common laboratory instrumentation like GLC, HPLC, AA and spectrophotometers is preferred.

This is both an exciting short‑term role to be an integral part of the build out, and will ensure a long term, stable position with success!

Responsible for the oversight, training, and development of all laboratory technicians.

Ensure compliance with all clean room safety and quality requirements.

Accountable for all incoming, in‑progress and final product testing

Monitors and communicates non‑conformances to department supervisors and senior managers.

Recommends measures to improve methods, quality of product.

Recommends and implements changes in working conditions and use of equipment to increase efficiency of the department.

Supervises and maintains all lab instrumentation. Responsible for qualification and calibration of all lab equipment.

Responsible for validation of test procedures. Verifies all results.

Verifies the batch records and the laboratory tests for the API’s and excipients and recommends the final approval for the batches.

Elaborates the certificates of analysis for API’s and excipients and submit them to the Quality Manager to be signed; in the absence of Quality Manager, signs the certificates of analysis for API’s and excipients.

Prepares and distributes precise and timely reports as required.

Oversees maintenance of all quality control records and samples.

Responsible for implementation of all quality system documents that are applicable in the lab

Performs all the activities detailed in the quality system procedures that are in conformity to the ISO 9001:2008 and cGMP Part II requirements

Develops new methods and plant support procedures.

Qualifications

Bachelor's Degree in Engineering (Chemical or Chemistry preferred), advanced degree desired

Min 3 years' experience in Chemical, Pharmaceutical, or similar experience required;

Min 1 year in a Supervisor role

GMP knowledge/experience

Ability to lead quality control

Demonstrated ability to set priorities, be flexible and manage multiple projects simultaneously.

Proven ability to work in fast‑paced, detailed, and deadline‑oriented environment by balancing multiple priorities and resources simultaneously.

Excellent communication, interpersonal skills and interacts well with external customers, visitors, employees and management in other departments

Computer literate with advanced writing skills.

Can initiate tasks and work in an independent manner.