Staff Process Specialist - Manufacturing

About the role

The Staff Process Specialist - Manufacturing position provides on the floor direction on the manufacturing process. Key member in the implementation of the manufacturing production program.

Responsibilities

• Provides technical input to resolve process problems both on and off the production suites
• Coaches manufacturing personnel to increase technical knowledge of critical process steps on the floor
• Supports Manufacturing personnel on implementing improvements to the process or work systems in the suites
• Supports CAPA implementation on process related improvements
• Supports onsite educational programs to enhance technical competence of manufacturing personnel
• Supports all aspects of the manufacturing process according to approved protocols, regulation, and schedule
• Supports the technology transfer of the manufacturing process
• Liaises with the process science/technology transfer teams in relation to the transfer and startup of the manufacturing process
• Prepares reports by collecting, analyzing, and summarizing information and trends
• Leads investigations into process variances according to site procedures
• Ensures that policies and procedures are effectively administered and that they comply with regulatory requirements
• Communicates well with supervisors on major problems regarding the process, schedules and materials
• Guides and oversees validation activities involving manufacturing equipment and processes
• Interfaces with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control
• Works to the highest safety standards. Supports safety improvements which require technical/engineering input
• Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently
• Performs cGMP audits of production area
• Represents manufacturing during regulatory and client audits. Will also respond to some of the findings from these audits
• Writes, reviews, and/or approves Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed
• Leads and implements continuous improvement initiatives
• Acts as system owner for defined manufacturing equipment and schedules all non-routine activities for that equipment

Requirements

• Knowledge of cGMP manufacturing environment and familiarity with formulation, aseptic filling, visual inspection (manual and automated), assembly, labeling, and/or packaging of liquid and lyophilized injectable products
• Demonstrated strong interpersonal, cross-cultural, communication, negotiation, and problem-solving skills
• Exhibits confidence, has a high emotional IQ, and demonstrated ingenuity, creativity and resourcefulness
• Ability to gain understanding from provided instructions and work towards established goals individually or as part of a team
• Ability to understand and listen to team members and stakeholders needs while supporting a positive team environment
• Technology transfer and equipment / process validation experience of aseptic, parenteral fill/finish operations preferred
• Previous experience providing technical support preferred
• Experience with lyophilization is a plus
• Experience with operating and qualifying equipment with high levels of automation is a plus

Qualifications

• BS in Life Sciences or related field and 8 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry or equivalent combination of education and experience
• 10 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry for Staff Process Specialist
• 12 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry for Senior Staff Process Specialist

Skills

• Technical expertise in cGMP manufacturing environment
• Strong interpersonal and communication skills
• Problem-solving and analytical skills
• Leadership and team management skills
• Experience with lyophilization and equipment validation

Benefits

• Comprehensive health and wellness programs
• Flexible work arrangements
• Retirement savings plan
• Employee assistance program
• Professional development opportunities

Pay

$92,200.00 - $206,100.00 annually

Schedule

Full-time