Project Manager

Details:

Job Title: Project Manager

Pay Rate: $64.75 - $71.95 / hr

Location: Thousand Oaks, CA

Area Code: 805, 820

ZIP Code: 91320

Start Date: Right Away

Keywords: #ProjectManager #ProjectManagement

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:

FULLY ONSITE AT USTO

Standard business hours

Looking for a PM who will support manufacturing plant/ engineering group

This engineering position supports projects that associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer will lead activities in alignment with the engineering workstreams (i.e. Amgen"s Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & facilities design and compliance, project management, etc.). The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment. The engineer must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance. 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.

The Engineer role will provide direct engineering technical support as follows:

• Be individually accountable for the verification deliverables on key capital projects

• Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.

• Assist in development and review of User Requirements Specifications (URS).

• 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) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).

• 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 validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.

• Ensure safety during commissioning, validation, maintenance, and manufacturing activities

• Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed

• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable

• Suggest design modifications to address risks and design in quality and safety

• Develop commission strategy

• Oversee development of validation protocols, Automation System Delivery

• Lead teams

Related Activities:

• Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.

• Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.

• Provide ad hoc technical support and guidance for manufacturing and maintenance

• Assist in developing and project engineering & management metrics

Preferred Qualifications / Skills / Experience

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

• 2+ years of relevant work experience with 1+ 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 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

• Experience with combination product / medical device quality systems verification

• Process equipment knowledge - cell culture, fermentation, purification, filling, and packaging

• Process automation knowledge - understanding of automation infrastructure, current technologies, and automation project execution / verification.

o Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus

• Demonstrated strong communication and technical writing skills

• Strengths in facilitation and collaboration / networking

• 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

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

• Demonstrated skills in the following areas:

Problem solving and applied engineering.

Basic technical report writing.

Verbal communication.

• Demonstrated Skills in the following areas:

Basic technical presentations.

Personal Organization.

Dealing with and managing change.

Technical (Equipment Specific).

Analytical Problem Solving.

Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS).

• Specialized equipment/process expertise.

• Ability to handle multiple projects at the same time.

• Demonstrated Skills in the following areas:

Schedule development

Facilitation

Collaboration

Basic project management

Completion and follow-up

• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.

• Demonstrated Skills in the following areas:

Negotiation, persuasion, and facilitation collaboration

Project cost development

Conflict resolution

Leadership and team building

Schedule and resources loading development

Customer service in a technical setting

Management of contractors and vendors.

Flexibility to work off-hours.

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