**Process Engineer

Contract
Title or Role: Process Engineer
Location: Parsippany, NJ
Length of Contract: 4 months
Responsibilities:

• CAPA closure on an FDA BPDR (239368)
  • Complete engineering feasibility study to determine if sonication capabilities can be added upstream of vial washer.
  • Perform engineering study on vial washer using riboflavin and potentially microsphere suspensions and develop washing cycle if required.

• nnex 1 Gap Remediation
  • Number of Cycles for Air Filters (Process Engineer) - we currently replace air filters every six months during our shutdown. Create justification for maximum duration of use on vent filters and create integrity testing for pre-use and captured as part of the changeout. Process equipment should have a defined number of cycles that can be captured between changeout of filters.
  • Bubble room (HVAC Engineer): Require rationale for the need of the bubble room and justify the alarm setpoints between each grade throughout the suite. Feasibility study to determine if clean room suite air supply can be retrofitted to supply air that maintains positive pressure and remove the need for the bubble room.

Qualifications:

• Process Engineer should possess at a minimum five (5) years of experience in pharmaceutical support, process engineering and process validation. Knowledge of EMEA (Annex 1) and FDA (21CFR200s, 210s, 600s)

Equal Opportunity Statement:
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.
Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
bout RCM:
RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.