Belcan Engineer Senior - Thousand Oaks, California
Keywords: #SeniorEngineer #Manufacturing
Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision options available.
On-the-job training and cross-training to develop skills, creating opportunities 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.
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.
Responsibilities:
FULLY ONSITE AT USTO, Standard business hours.
Looking for hands-on engineering experience with proper training/background in technical side/mathematics. NOT LOOKING for quality lab/benchtop/science work.
The job seeker needs to be practical with troubleshooting and be able to hold a technical conversation.
Industry background: Drug substance/pharma/chemical/oil refinery/mechanical.
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Client Thousand Oaks (ATO). The senior engineer works in partnership with various teams to develop and oversee the operation and reliability of equipment while driving safety and quality compliance.
The Senior Engineer role will provide direct engineering technical support as follows:
- Demonstrating leadership behaviors and positive values to create a positive working environment.
- Accountable for manufacturing equipment reliability and deliverables on key capital projects.
- Assist in identifying critical quality parameters and process attributes for new equipment or facility modifications.
- Suggest design modifications to address risks and design in quality and safety.
- Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES).
- Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.
- Recommend, evaluate, and manage performance of contract resources.
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Act as a liaison between engineering and quality assurance during project planning, execution, and closeout.
- Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation.
- Review and approve the commissioning reports, maintenance practices and parts, and drive productivity improvement.
Related Activities:
- Participate or lead multidisciplinary site teams.
- Support Lean Transformation and Excellence in Operations process improvement.
- Provide ad hoc technical support and guidance for manufacturing and maintenance.
- Provide coaching and guidance to project teams and engineers.
- Defend the equipment-specific calibration, maintenance, & validation during regulatory inspections.
- Participate in internal audits and assess in conjunction with quality assurance.
- Assist in developing and maintaining business metric performance.
Basic Qualifications:
Doctorate degree OR Master’s degree & 3 years of engineering and/or manufacturing experience OR Bachelor’s degree & 5 years of engineering and/or manufacturing experience OR Associate’s degree & 10 years of engineering and/or manufacturing experience OR High school diploma/GED & 12 years of engineering and/or manufacturing experience.
Preferred Qualifications / Skills / Experience:
- Bachelor's degree in engineering or another science-related field.
- 7+ years of relevant work experience with 5+ years experience in operations/manufacturing environment.
- Direct experience with regulated environments (FDA, OSHA, EPA, etc.).
- Working knowledge and experience with cGMP procedures and engineering practices.
- Experience implementing risk-based verification on major GMP process equipment/automation projects.
- Strong process equipment knowledge - cell culture, fermentation, purification, filling, and packaging.
- Strong process automation knowledge.
- Demonstrated strong communication and technical writing skills.
- Strengths in facilitation and collaboration/networking.
- Experience in developing SOPs and delivering training.
- Proven track record of applying process improvement methodologies.
If you are interested in this role, please apply via the apply now link provided. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity. For more information, please visit our website at
Location: Thousand Oaks, CA
Minimum Experience (yrs): Required Education: Master (MA, MS...)
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