Instrumentation and Controls Engineer

  • Location
    Raleigh, North Carolina
  • Job type
    Direct Hire
  • Category
    Engineering - Mechanical

Adecco Executive Recruitment has an exciting New Direct Hire opportunity as an Instrumentation and Controls Engineer in the Pharmaceutical/Biotechnology industry with our client in Raleigh, NC.

In this role you will, authors, execute, and summarize validation protocols. Coordinate and leads validation project execution for equipment, critical utilities, cleaning validation, and computer related systems. You will ensure protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP) and approved SOPs. Additionally, you will support investigations for critical equipment, processes, and utilities. This person is expected to be a SME (Subject Matter Expert) for site compliance related functions including Validation.

ESSENTIAL FUNCTIONS:
1. Coordinate and execute validation studies, writing protocols, and documenting results.
2. Generate final reports and summaries of work performed.
3. Possesses a mechanical aptitude.
4. Ability to generate summaries of work for release of equipment tested.
5. Ability to troubleshoot protocol deviations and summarize actions in a report format.
6. Develops and revises new or existing procedures to insure compliance to cGMP, GLP, and regulations.
7. Provides technical advice on new equipment or utilities.
8. Ability to assess statistical process data such as autoclave and washer cycle runs.
9. Provides insight into modification of existing equipment to ensure validation/qualification status is maintained in a state of control.
10. Provides technical assistance and training for personnel.
11. Recommends changes in policies and procedures, to management, to enhance the company's ability to conform to and maintain compliance with site, corporate and regulatory standards.
12. Notifies and recommends to management course of action when critical instruments, systems or processes are found to be out of specifications.
13. Working knowledge of change management and change control requirements.
14. Knowledge and experience in general validation activities such as URS, FS, DS, FAT, SAT, IQ/OQ/PQ
15. Assist in change control evaluations and test plans.
16. Ability to read, analyze, and interpret validation protocols, SOPs, technical procedures, or governmental regulations
17. Working knowledge of the fundamentals of steam sterilization, cleaning validation, and equipment qualification.
18. Knowledge of key manufacturing equipment such as autoclaves, formulation/hold tanks, and filling/packaging equipment trains.
MINIMUM REQUIREMENTS:

Education required/ preferred: BS degree in engineering/life sciences or equivalent validation experience
5 years of industrial in regulated industry preferable food beverage, pharma, or biotech
Minimum of 2 years supervisor calibration, instrumentation group
No Relocation

Experience Desired:

Minimum 7 years’ experience within the pharmaceutical industry
Previous experience in Validation or Engineering required
Ability to utilize MS Office (Word, Excel, PowerPoint, Access)
Preferred Skills/Qualifications:
CSV SME o Experience in product contact cleaning including the use of swabs and plates
Knowledge of GAMP4/5 and application of Risk Based approaches to Validation o Able to balance resources, voice of the customer, and timelines, while implementing robust and defendable validation doctrines
ValProbe and Kaye Validators experience
Ability to comprehend and apply principles of calculus, modern algebra, and advanced statistical theory. Ability to define problems, collects data, establish facts, and draw valid conclusions from these observations o Industry guideline knowledge of 21 CFR part 11, 21 CFR part 210, 21 CFR part 211, IPSE, PDA, MHRA, PICs, MFDS


If you are interested in applying to this position or referring a candidate, please email professional resumes to phil.winborne@adeccona.com for consider or apply directly.

  • Apply with Adecco

Reference number US_EN_2_027442_136884