Sr. Automation Engineer

Posted 3 Days Ago
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Manatí
Senior level
Biotech • Pharmaceutical
The Role
The Sr. Automation Engineer at Cencora PharmaLex will provide engineering support in a manufacturing environment, focusing on Pharmaceutical and Biotechnology operations. Responsibilities include process control, troubleshooting, commissioning, and validation of bioprocess systems. The role requires strong analytical and leadership skills to work in a collaborative, regulated environment, applying knowledge of automation platforms and validation protocols.
Summary Generated by Built In

JOIN OUR TEAM!

Cencora PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. Cencora PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
 PREFERRED QUALIFICATIONS

  1.  5+ years of engineering experience in a manufacturing support environment with at least 3 years experience in the Pharmaceutical or Biotechnology industries.
  2. Experience in Drug Substance Operations with Mammalian Cell Culture, Protein Purification, Media and Buffer Preparation, Clean Utilities, CIP, SIP and Production Services.
  3. Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.
  4. Experience with Tech Transfer, Process Design, Commissioning, validation and change control methodology.
  5. Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.
  6. Excellent written and verbal communication skills and the ability to work with minimum direction.
  7. Interpersonal and facilitation skills and ability to work in a collaborative team based environment.
  8. Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information.
  9. Ability to lead and influence cross-functional teams and embrace a team-based culture.
  10.  In-depth knowledge on Rockwell Automation Platform and Allen-Bradley
  11. Strong knowledge in programing language
  12. Direct hands on experience with lifecycle management of Rockwell hardware and software infrastructure preferred.
  13. Understanding of Operational Excellence and Lean transformation in the automation and engineering Context.
  14.  Ability to create, update and read P&IDs, instrumentation and electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
  15. Work schedule flexibility to support 24/7 operations and after-hours engineering coverage.
  16. Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
  17. Familiarity with validation processes and documentation in a highly regulated environment.
  18. Comprehensive understanding of validation protocol execution and knowledge of validation processes as applied to new equipment installations.

Skills in the following areas:

  • Problem solving and applied engineering
  • Verbal and writing communications in English and Spanish
  • Validation Protocol Writing
  • Dealing with and managing change

PharmaLex is an Equal Opportunity Employer.

Top Skills

Programming Language
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The Company
HQ: Burlington, MA
1,385 Employees
On-site Workplace
Year Founded: 1994

What We Do

PharmaLex is a leading provider of specialized services for the pharma, biotech and medtech industries.

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval/maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results - going above and beyond the standard to deliver tailor-made solutions worldwide.

The PharmaLex Group now has over 3000 employees, with 68 offices in 32 countries and more than 1000 satisfied clients worldwide.

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