Engineer

Details:

Job Title: Engineer x

Pay Rate: $41.06/hr.

Location: Thousand Oaks, CA

ZIP Code: 91320

Start Date: Right Away

Keywords: #Engineering

Benefits:

• Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision / glasses / prescription contact lens and eye test options available.

• On the job training / cross-training to develop and expand skills, creating opportunity for advancement and personal development. Tuition reimbursement available for relevant development opportunities.

• Life Insurance, disability insurance, and voluntary life insurance for family members available. Accident and critical illness insurance optional.

• Scheduled performance reviews create opportunities for advancement and pay increases.

• We have many success stories from individuals who took advantage of the training, cross-training, and personal development opportunities for advancement. We also have success stories of individuals who desired a reliable, scheduled and consistent career with appropriate work-life balance, health benefits and good job security. Whichever way you define success, this work culture cares about team members and treats each individual with dignity, inclusion, respect and recognition.

• A Referral Program compensates active employees for referring friends and former colleagues when the referral results in hiring the person. Our team has grown with referrals and internal promotions.

Responsibilities:

Onsite - 100% Thousand Oaks, CA

Must be local- not interested in seeing job seekers who will need to relocate

Must be available for potential on call for Overtime looking at potentially 10-12 hours a month.

This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Client Thousand Oaks (ATO). The engineer will lead activities in alignment with Client's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance, project management, the engineering technical lead, and manufacturing to develop and oversee the implementation, operation and reliability of equipment. The engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition, the engineer will evaluate equipment maintenance plans, support periodic review of manufacturing systems, and investigate root causes of equipment issues. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.

Preferred Qualifications / Skills / Experience

• Bachelor's degree in engineering or another science-related field

• 2+ years of relevant work experience in operations/manufacturing environment

• Direct experience with regulated environments (FDA, OSHA, EPA, etc.)

• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment

• Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution

• Demonstrated strong communication and technical writing skills

• Strengths in facilitation and collaboration / networking with cross-functional groups

• Experience in developing SOPs and delivering training

• Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making

• Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)

• Problem solving skills using scientific and engineering methods and investigative skills for root cause analysis.

• Availability to support outside regular hours as needed

• Demonstrate skills in the following areas:

Problem solving and applied engineering.

Basic technical presentations.

Personal organization.

Adapting to and managing change.

Project and document management systems (CDOCS, E-Builder, PCS, BMS and QEMS).

Validated GMP management systems (Maximo CMMS, Trackwise)

Project management and cost development

Conflict Resolution

Leadership and team building

If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com

EOE/F/M/D/V