Manufacturing Technical Specialist
American Cybersystems, Inc.

Innova Solutions is immediately hiring for Manufacturing Technical Specialist

Position type: Full time Contract
Duration: 10+ Months
Location: Oceanside, CA

As a Manufacturing Technical Specialist you will:

Description
Primary Responsibilities:

• The OSUT is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 3 clinical trials and commercial products.
• The OSUT will employ a ballroom design utilize single-use technology new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility.
• We are looking for individuals to support this facility who are comfortable with ambiguity have an entrepreneurial spirit within a GMP environment have demonstrated strong Pharma Technical Behaviors and have an agile mindset.
• Ability to collaborate is crucial as success will be measured as a member of a team not just as an individual.
• Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production.
• The team members will work closely with the existing staff in the stainless steel operations as well as Clinical Supply Center CSC.
• In this role the qualified individual will be part of the Operations Process Support and Process Engineering team that starts up the facility.
• There will be one team that will support the entire process from initial cell bank thaw through bulk freeze.
• Team members will support manufacturing operations upstream and downstream but will also have responsibility for technical evaluations troubleshooting and work with the project team on equipment or consumable design.
• The candidate will engage with customer groups network teams and project teams to seek opportunities for collaboration proactively communicating and presenting information and offering relevant data driven information to impact decisions.
• OSUT Manufacturing Core is fully qualified up to OQ and can be released for GMP use.

Deliverables and Milestones -

• Successful Automation SAT completion
• Completion of Operation Verification
• Successful Water Run for Process Equipment completion
• Successful Technical Run for Process Equipment completion

Primary Responsibilities:

• Reviews approves validation documents and protocols
• Participates in safety assessments/reviews
• Ensures necessary operating procedures are in place prior to CQ execution on the assigned unit operations
• Ensures training materials and curriculum are developed and revised as needed
• Performs/updates risk assessments in partnership with network and Quality counterparts
• Coordinates and conducts start-up and troubleshooting activities.
• Execute equipment CQ write-up and review using existing documentation and protocols.
• Collaborate with the Automation engineering team to coordinate control systems design installation and commissioning needed for the core processing systems.

Qualifications: Target Experience Knowledge:

• 15 or more years work experience in the pharmaceutical or related industry
• 10 or more years direct or indirect people and team management experience
• 5 or more years work experience in a cGMP regulated environment preferably in biologics manufacturing Prefer experience knowledge working with Single Use Technologies or modular operations

Skills Competencies:

• Excellent verbal and written communication skills
• Excellent business acumen
• Ability to influence at all levels of an organization
• Builds trustful and effective relationships
• Thinks strategically and translates strategies into actionable plans
• Takes responsibility drives results and achieves expected outcomes
• Comfortable working in an agile and ambiguous environment
• Has demonstrated a commitment to quality bull Bachelor's Degree required science or engineering is preferred bull Professional Graduate or higher-level degree is preferred Work Environment/Physical Demands/Safety Considerations

• Work in office manufacturing and to a lesser extent laboratory environment.
• May be on feet for 4 to 5 hours a day.
• Able to work a flexible schedule to meet start-up activity requirements. - Lifting up to 25lbs may be required.
• May work in the clean room environment that requires gowning in the form of hospital scrubs coveralls gloves and steel toe boots be worn.
• Also no makeup or jewellery can be worn when working in the clean room environment.
• May work with hazardous materials and chemicals.

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!

PRATEEK GODSE
PHONE (+1) 425 -296-4378
EMAIL (Prateek.godse@innovasolutions.com)

PAY RANGE AND BENEFITS:
Pay Range*: $76- $81 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centres across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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