Senior Associate Facilities, Biopharma; JP

Position: Senior Associate Facilities, Biopharma (JP13056)
Job Title: Senior Associate Facilities, Biopharma (JP13056)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities and Engineering Drug Substance Supply group.
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate
:
Open Market Rate W2
Posting Date: 8/19/2024.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting a Senior Associate, Facilities for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
We are looking for a Sr. Associate Facilities to provide maintenance leadership and technical expertise in support of facility equipment/systems, utility systems, and/or production suites, ensures systems operate within designed parameters. Area of responsibility may consist of multiple facilities, disciplines, or clients. All work to be completed to assure minimal impact to production while complying with all safety / cGMP guidelines and client procedures.

Top Must Have Skill Sets:

• Technical Skills Regarding Facilities Engineering
• Great Communication Skills
• Teamwork
• Resumes need to be thorough and carry a strong level of documentation of previous experience and how its relatable to this role and it's requirements !

Day to Day Responsibilities:

• Directing/planning/delegating of tasks to personnel in daily operations, corrective action, and preventative maintenance activities in a reliable and compliant manner. This includes, but is not limited to, maintenance and emergency repair of all production related utilities and facility equipment that support GMP production:
  • HVAC, HEPA certifications, and pressure cascades, water purification systems, plant and clean steam, chillers and clean gas systems.

Additionally, the staff will need to understand room classification and gowning requirements. Alarms and associated subject matter expertise will be provided to triage events impact to quality or safety. Fundamental control system strategy and logic will need to be understood to troubleshoot and provide data trends from EMS/BMS/USC systems.

• Create, edit, or obsolete training with associated equipment systems and evaluate staff proficiency to qualification records.
• Development and maintain the current repair job plans and spares inventory control for associated equipment
• Interact with various support teams for integrated contracted partners for calibration support and outside vendors that provide contracted maintenance
• Assure quality and safety change control procedures are followed and changes are approved prior to execution and purchases being approved.
• Work to be completed in accordance with CFRs, cGMPs, SOPs and client policies
• Participate in On-Call rotations for after-hours facility and Manufacturing support and may work outside of established shift hours upon short notice

Basic Qualifications:
Master’s degree OR Bachelor’s degree and 2 years of maintenance experience OR Associate’s degree and 6 years of maintenance experience OR High school diploma / GED and 8 years of maintenance experience

Preferred Qualifications:

• 2 year technical/AA/AS degree in building maintenance, Mechanical maintenance, Plant engineering or related technical discipline.
• 7+ years combined education and experience with 4+ years in an FDA (GMP) or comparable regulated nvironment
• Experience with RCA facilitation and participation
• Experience with RCM, TPM, or other reliability centered concepts
• Experience with installation, troubleshooting, maintenance, repair and testing of HVAC, laboratory and utilities equipment
• Advanced Knowledge of pneumatic, mechanical, and hydraulic fundamentals as well as advanced skills in the use of power and hand tools in the building trades such as carpentry, plumbing, and electrical
• Effective oral and written communication skills
• Possess a high mathematical understanding, excellent reading skills along with intermediate to advanced computer and typing skills

Red Flags:

• Lack of Technical Details
• Poor Communication and Teamwork
• Lack of engagement

Why is the Position Open?
Supplement additional workload on team

Interview Process:

• Interview Process:
• Web Ex

We invite qualified candidates to sendyour resume  Ifyou decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our  You are also welcome to sharethis opportunity with anyone you think might be interested in applying for this role.
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